Seal-G MIST (Minimally Invasive Sealant/Spray Technology) System Safety Study [SEALAR Study]
Ontology highlight
ABSTRACT:
DISEASE(S): Diverticulitis Colon,Diverticulitis, Colonic,Diverticulitis,Colorectal Cancer
PROVIDER: 2267076 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:ObjectiveThis study evaluated the ergonomics and time requirements of using a novel automated suturing and titanium fastener deployment technology for chordal replacement in human heart specimens in open and minimally invasive cardiac surgery (MICS) simulators.MethodsFive cardiac surgeons used novel, manually powered expanded polytetrafluoroethylene (ePTFE) suturing devices to automate suture placement between mitral leaflets and papillary muscles in explanted cadaver hearts, along with customized titanium fastener delivery devices to secure suture and trim suture tails. This mitral chordal replacement test was conducted using surgical models simulating open and MICS mitral repair access. The study was approved by the institutional ethical board.ResultsAfter a brief introduction to this technique using plastic models, study surgeons performed 48 chordal replacements in human mitral valves, placing 18 in an open model and 30 in a right minithoracotomy model. The time range to complete a single chordal replacement was between 55 s and 8 min, with an overall mean duration of 3.6 ± 1.5 min. No difference in duration of implantation was recorded for the MICS and open sternotomy simulators used. Good control of suture delivery was reported in 95.8% (n = 46) of leaflet aspect of the sutures and in 100% (N = 48) of papillary muscle sutures.ConclusionsAutomated mitral chordal ePTFE suturing simulated through open and MICS access demonstrated quality handling and accurate placement of sutures in human heart specimens. A clinical trial using this technology is currently ongoing. This innovation may present an important advance facilitating enhanced minimally invasive mitral valve repair.
| S-EPMC9846373 | biostudies-literature
Project description:Right colectomy (hemicolectomy) involves the removal of the cecum, the ascending colon, the hepatic flexure, the first one-third of the transverse colon, part of the terminal ileum, and the associated regional fat and lymph nodes, and is the accepted treatment for malignant neoplasms of the right colon.
A minimally invasive approach is commonly used for right colectomy, with studies reporting reduced complications, less blood loss, and hospital stay when compared to an open approach.
However, there remains controversy regarding whether robotic assistance is advantageous for this technique and whether an intracorporeal (ICA) or extracorporeal anastomosis (ECA) is best.
MIRCAST is a prospective, observational, international, multi-center, 4-parallel-cohorts study. Sites or surgeons will select a cohort of the study for which they are qualified. Four cohorts will be the subject of study:
1. Robotic Right Colectomy with ICA
2. Robotic Right Colectomy with ECA
3. Laparoscopic Right Colectomy with ICA
4. Laparoscopic Right Colectomy with ECA
All patient assessments will be done according to the sites standard of care. Parameters routinely recorded during right colectomy surgery will be collected prospectively. Enrolled subjects will undergo assessments at the following intervals: pre-operative, operative, discharge, 30 days, 3 months, 1 year and 2 years post-surgery.
| 2282553 | ecrin-mdr-crc
Project description:Global health practitioners and policymakers have become increasingly vocal about the complex challenges of identifying and quantifying the causes of death of the world's poorest people. To address this cause-of-death uncertainty and to minimise longstanding sensitivities about full autopsies, the Bill and Melinda Gates Foundation have been one of the foremost advocates of minimally invasive autopsy technology (MIA). MIA involves using biopsy needles to collect samples from key organs and body fluids; as such, it is touted as potentially more acceptable and less invasive than a complete autopsy, which requires opening the cadaver. In addition, MIA is considered a good means of collecting accurate bodily samples and can provide the crucial information needed to address cause-of-death uncertainty. In this paper, we employ qualitative data to demonstrate that while MIA technology has been introduced as a solution to the enduring cause-of-death uncertainty, the development and deployment of technologies such as these always constitute interventions in complex social and moral worlds; in this respect, they are both the solutions to and the causes of new kinds of uncertainties. We deconstruct the ways in which those new dimensions of uncertainty operate at different levels in the global health context.
| S-EPMC9988304 | biostudies-literature
Project description:Smartphones contain powerful and enabling technology components that can be re-applied toward procedural tasks commonly used in everyday clinical image-guided therapies and minimally invasive procedures that use three-dimensional information and feedback during procedures. Smartphone applications are a relatively young field of research that have potential in interventional radiology (IR) toward improvement of accuracy and standardization for needle-based procedures like biopsy and ablation. This review explores the adaptation of smartphones' built-in sensors for virtual and augmented reality uses in IR. The ergonomic advantages and translational hurdles and limitations are reviewed, outlining the potential future developmental pathway of smartphones in IR.
| S-EPMC11790737 | biostudies-literature
Project description:Our aim is to review the benefits as well as techniques, surgical outcomes, and complications of minimally invasive inguinal lymph node dissection (ILND) for penile cancer. The PubMed, Wiley Online Library, and Science Direct databases were reviewed in March 2020 for relevant studies limited to those published in English and within 2000-2020. Thirty-one articles describing minimally invasive ILND were identified for review. ILND has an important role in both staging and treatment of penile cancer. Minimally invasive technologies have been utilized to perform ILND in penile cancer patients with non-palpable inguinal lymph nodes and intermediate to high-risk primary tumors or patients with unilateral palpable non-fixed inguinal lymph nodes measuring less than 4 cm, including videoscopic endoscopic inguinal lymphadenectomy (VEIL) and robotic videoscopic endoscopic inguinal lymphadenectomy (RVEIL). Current data suggest that VEIL and RVEIL are feasible and safe with minimal intra-operative complications. Perhaps the strongest appeal for the use of minimally-invasive approaches is their faster post-operative recovery and less post-operative complications. As a result, patients can tolerate this procedure better and surgeons can offer surgery to patients who otherwise would not be a candidate or personally willing to undergo surgery. When compared to open technique, VEIL and RVEIL have similar dissected nodal count, a surrogate metric for oncological adequacy, and a none-inferior inguinal recurrence rate. Larger randomized studies are encouraged to investigate long-term outcome and survival rates using these minimally-invasive techniques for ILND.
| S-EPMC7465352 | biostudies-literature
Project description:ImportanceAlthough robotic surgery has become an established approach for a wide range of elective operations, data on its utility and outcomes are limited in the setting of emergency general surgery.ObjectivesTo describe temporal trends in the use of laparoscopic and robotic approaches and compare outcomes between robotic and laparoscopic surgery for 4 common emergent surgical procedures.Design, setting, and participantsA retrospective cohort study of an all-payer discharge database of 829 US facilities was conducted from calendar years 2013 to 2021. Data analysis was performed from July 2022 to November 2023. A total of 1 067 263 emergent or urgent cholecystectomies (n = 793 800), colectomies (n = 89 098), inguinal hernia repairs (n = 65 039), and ventral hernia repairs (n = 119 326) in patients aged 18 years or older were included.ExposureSurgical approach (robotic, laparoscopic, or open) to emergent or urgent cholecystectomy, colectomy, inguinal hernia repair, or ventral hernia repair.Main outcomes and measuresThe primary outcome was the temporal trend in use of each operative approach (laparoscopic, robotic, or open). Secondary outcomes included conversion to open surgery and length of stay (both total and postoperative). Temporal trends were measured using linear regression. Propensity score matching was used to compare secondary outcomes between robotic and laparoscopic surgery groups.ResultsDuring the study period, the use of robotic surgery increased significantly year-over-year for all procedures: 0.7% for cholecystectomy, 0.9% for colectomy, 1.9% for inguinal hernia repair, and 1.1% for ventral hernia repair. There was a corresponding decrease in the open surgical approach for all cases. Compared with laparoscopy, robotic surgery was associated with a significantly lower risk of conversion to open surgery: cholecystectomy, 1.7% vs 3.0% (odds ratio [OR], 0.55 [95% CI, 0.49-0.62]); colectomy, 11.2% vs 25.5% (OR, 0.37 [95% CI, 0.32-0.42]); inguinal hernia repair, 2.4% vs 10.7% (OR, 0.21 [95% CI, 0.16-0.26]); and ventral hernia repair, 3.5% vs 10.9% (OR, 0.30 [95% CI, 0.25-0.36]). Robotic surgery was associated with shorter postoperative lengths of stay for colectomy (-0.48 [95% CI, -0.60 to -0.35] days), inguinal hernia repair (-0.20 [95% CI, -0.30 to -0.10] days), and ventral hernia repair (-0.16 [95% CI, -0.26 to -0.06] days).Conclusions and relevanceWhile robotic surgery is still not broadly used for emergency general surgery, the findings of this study suggest it is becoming more prevalent and may be associated with better outcomes as measured by reduced conversion to open surgery and decreased length of stay.
| S-EPMC10918578 | biostudies-literature
Project description:Cardiac tissue slices preserve the heterogeneous structure and multicellularity of the myocardium and allow its functional characterization. However, access to human ventricular samples is scarce. We aim to demonstrate that slices from small transmural core biopsies collected from living donors during routine cardiac surgery preserve structural and functional properties of larger myocardial specimens, allowing accurate electrophysiological characterization. In pigs, we compared left ventricular transmural core biopsies with transmural tissue blocks from the same ventricular region. In humans, we analyzed transmural biopsies and papillary muscles from living donors. All tissues were vibratome-sliced. By histological analysis of the transmural biopsies, we showed that tissue architecture and cellular organization were preserved. Enzymatic and vital staining methods verified viability. Optically mapped transmembrane potentials confirmed that action potential duration and morphology were similar in pig biopsies and tissue blocks. Action potential morphology and duration in human biopsies and papillary muscles agreed with published ranges. In both pigs and humans, responses to increasing pacing frequencies and β-adrenergic stimulation were similar in transmural biopsies and larger tissues. We show that it is possible to successfully collect and characterize tissue slices from human myocardial biopsies routinely extracted from living donors, whose behavior mimics that of larger myocardial preparations both structurally and electrophysiologically.
| S-EPMC7673124 | biostudies-literature
Project description:With the increase in Natural Orifice Transluminal Endoscopic Surgery procedures, there is an increasing demand for surgical instruments with additional degrees of freedom, able to travel along tortuous pathways and guarantee dexterity and high accuracy without compromising the surrounding environment. The implementation of follow-the-leader motion in surgical instruments allows propagating the decided shape through its body and moving through curved paths avoiding sensitive areas. Due to the limited operational area and therefore the instrument size, the steerable shaft of these instruments is usually driven by cables that are externally actuated. However, a large number of degrees of freedom requires a great number of actuators, increasing the system complexity. Therefore, our goal was to design a new memory system able to impose a follow-the-leader motion to the steerable shaft of a medical instrument without using actuators. We present a memory mechanism to control and guide the cable displacements of a cable-driven shaft able to move along a multi-curved path. The memory mechanism is based on a programmable physical track with a mechanical interlocking system. The memory system, called MemoBox, was manufactured as a proof-of-concept demonstration model, measuring 70 mm × 64 mm × 6 mm with 11 programmable elements and featuring a minimum resolution of 1 mm. The prototype shows the ability to generate and shift complex 2D pathways in real-time controlled by the user.
| S-EPMC9632848 | biostudies-literature
Project description:Benign prostatic hyperplasia (BPH) represents a spectrum of related lower urinary tract symptoms (LUTS). The cost of currently recommended medications and the discontinuation rate due to side effects are significant drawbacks limiting their long-term use in clinical practice. Interventional procedures, considered as the definitive treatment for BPH, carry a significant risk of treatment-related complications in frail patients. These issues have contributed to the emergence of new approaches as alternative options to standard therapies. This paper reviews the recent literature regarding the experimental treatments under investigation and presents the currently available experimental devices and techniques used under local anesthesia for the treatment of LUTS/BPH in the vast majority of cases. Devices for delivery of thermal treatment (microwaves, radiofrequency, high-intensity focused ultrasound, and the Rezum system), mechanical devices (prostatic stent and urethral lift), fractionation of prostatic tissue (histotripsy and aquablation), prostate artery embolization, and intraprostatic drugs are discussed. Evidence for the safety, tolerability, and efficacy of these "minimally invasive procedures" is analyzed.
| S-EPMC4547646 | biostudies-literature
Project description:A modification of range of motion of the knee can significantly change a patient's quality of life. In general, range of motion of 0° to 125° is adequate for most activities of daily life. The rate of knee arthrofibrosis after ligament reconstruction is reported to be between 0% and 4%; after tibial fracture due to high-energy trauma, the rate is about 7%, with an undetermined incidence after limb lengthening. The purpose of this study was to describe a modification of the operative technique of Judet. We describe minimally invasive quadricepsplasty in 4 steps, aiming to obtain an end result with an arc of movement of at least 120° to 130°. We believe that our technique is a good option for the treatment of the stiff knee, having low morbidity and being an easy method to perform.
| S-EPMC6472174 | biostudies-literature