Clinical trials: Sutures
Bariatric - Sleeve Gastrectomy Staple Line Reinforcement, Gynecology - Vaginal Cuff Closure
Post-Market Clinical Follow-Up of STRATAFIX™ Spiral PDS™ PLUS
This single-arm, prospective, observational multicenter study will collect clinical data in a post-market setting across two different specialties in Robotic surgical procedures: Bariatric Sleeve gastrectomy (Staple line…
- Trial name
- NCT03937011
- Testing
- Robotic Suturing of gastric sleeve oversew and vaginal cuff closure
- Where
- 8 sites in United States, Germany and 1 more
- Volunteers
- 161 people
- Sponsor
- Ethicon, Inc.
Peripheral Arterial Disease, Arterial Puncture
The Safety and Efficacy of the Suture-Mediated Closure System
This was a prospective, multicenter, randomized, controlled, non-inferiority clinical study with the primary objective of validating the safety and efficacy of the Suture-Mediated Closure System for percutaneous closure of the…
- Trial name
- NCT05841836
- Testing
- the Suture-Mediated Closure System, Perclose ProGlide Suture-Mediated Closure System
- Where
- China
- Volunteers
- 228 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Laceration of Skin, Injury Skin
Assessment of DAFILON® Suture Material for Skin Closure
In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon®) will be evaluated for skin closure in adult and pediatric patients.
- Trial name
- SKINDA (NCT04617041)
- Where
- 2 sites in Germany, Spain
- Volunteers
- 115 people
- Sponsor
- Aesculap AG
Obesity
ULTIMATE Study for Weight Loss
The purpose of this study is to help find out more about how the Primary Obesity Surgery Endoluminal (POSE) procedure makes patients feel less hungry and fuller faster, leading to weight loss.
- Trial name
- ULTIMATE (NCT01771276)
- Testing
- g-Cath Suture Anchor Delivery Catheter
- Where
- Spain
- Volunteers
- 10 people
- Sponsor
- USGI Medical
Great Vessel Reconstruction, Peripheral Vessel Reconstruction
Post-Market Registry in Europe and US for the Use of VascuCelTM
This is a post-market, multi-centre, open-label registry designed to collect prospective safety and performance data on the use of VascuCel in patients who require great vessel reconstruction, peripheral vascular reconstruction…
- Conditions
- Great Vessel Reconstruction, Peripheral Vessel Reconstruction, Suture Line Buttressing
- Trial name
- VascuCel (NCT04906824)
- Testing
- great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing
- Where
- 5 sites in United States, Italy
- Volunteers
- 100 people
- Sponsor
- LeMaitre Vascular
Anterior Cruciate Ligament Injury, Rotator Cuff Tear
MDR EZ Pass and Precision Flexible Reamer
The objective of this study is to confirm the safety and performance on the EZPass Suture Passer Instrumentation and the Precision Flexible Reamer Instrumentation.
- Trial name
- NCT03914703
- Testing
- EZ Pass Suture Passer
- Where
- United States
- Volunteers
- 73 people
- Sponsor
- Zimmer Biomet
Vascular Closure, Femoral Arteriotomy Closure
The Ladera Suture-Mediated Large Bore Closure Study
This study evaluates the safety and performance of the Ladera Medical suture-mediated large bore closure (LBC) system in gaining post procedure hemostasis in subjects undergoing interventional catheterization procedures using a…
- Trial name
- FASTEN (NCT06851481)
- Testing
- Ladera LBC System
- Where
- 6 sites in Australia, Belgium and 1 more
- Volunteers
- 55 people
- Sponsor
- Ladera Medical
Tooth, Impacted, Teeth Impact
Performance of Safety of SILKAM® Suture Material in Oral Surgery
Assessment of SILKAM® suture material in mucosal closure in oral surgery (mucosal sutures). A prospective, monocentric, single arm observational study.
- Conditions
- Tooth, Impacted, Teeth Impact, Tooth Impaction, Mucosal Wound
- Trial name
- SILKOS (NCT05296902)
- Testing
- Mucosal Closure
- Where
- Spain
- Volunteers
- 105 people
- Sponsor
- Aesculap AG
Oral Surgery, Tooth Extraction
Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures)
In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adult patients
- Conditions
- Oral Surgery, Tooth Extraction, Dental Implants
- Trial name
- MUCODA (NCT04390620)
- Testing
- Mucosal Closure
- Where
- 2 sites in Germany, Spain
- Volunteers
- 105 people
- Sponsor
- Aesculap AG
Obesity
Incisionless Suture Plications in a POSE2.0 Obesity Study
This is a multi-center, open-label, 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure. The intent is to evaluate the safety and effectiveness of POSE2.0 (sutures placed in the mid + distal…
- Trial name
- INSPIRO (NCT06272201)
- Testing
- POSE2.0 procedure with g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors
- Volunteers
- 186 people
- Sponsor
- USGI Medical
Control of Local Bleeding in Patients Undergoing Prostatectomy.
Assess Efficacy and Safety of TachoComb H vs. Standard Surgical Treatment (i.e. Suturing) in Patients Undergoing Prostatectomy (TC-017-AU)
The overall objective is to compare efficacy and safety of TachoComb H versus standard surgical treatment for the control of local bleeding in patients undergoing prostatectomy.
- Trial name
- NCT00290836
- Testing
- Human fibrinogen/thrombin and bovine aprotinin (TachoComb H)
- Where
- Denmark
- Volunteers
- 120 people
- Sponsor
- Nycomed
Atrial Fibrillation
aMAZE Trial Continued Access Protocol
aMAZE CAP is an extension to the current aMAZE Trial investigation (IDEG150107/NCT02517397/Protocol Appendix 16) in the form of a nested, non-randomized registry, to allow ongoing treatment of subjects and the collection of…
- Trial name
- aMAZE CAP (NCT04468334)
- Testing
- LARIAT + PVI
- Where
- 25 sites in United States
- Volunteers
- 82 people
- Sponsor
- AtriCure, Inc.
Gastrointestinal Stromal Tumors, Gastrointestinal Neoplasms
Gastrointestinal Anastomosis Using MonoPlus® Suture
The primary aim of this study is to collect clinical data on the performance of MonoPlus® suture applied in routine clinical practice.
- Conditions
- Gastrointestinal Stromal Tumors, Gastrointestinal Neoplasms, Digestive System Neoplasm, Stomach Tumor
- Trial name
- GASTROMO (NCT04811833)
- Where
- 2 sites in Spain
- Sponsor
- Aesculap AG
Intracardiac and Septal Defects, Valve and Anulus Repair
Prospective and Non-randomized Registry of CardioCel 3D
Post-market, prospective, multi-centre, open-label, registry designed to collect prospective safety and performance data on the use of CardioCel in patients with cardiovascular disorders and in accordance with local standard of…
- Conditions
- Intracardiac and Septal Defects, Valve and Anulus Repair, Great Vessel Reconstruction, Peripheral Vessel Reconstruction
- Trial name
- NCT04175327
- Testing
- CardioCel implantation
- Where
- 6 sites in Germany, Italy and 2 more
- Volunteers
- 200 people
- Sponsor
- LeMaitre Vascular
Rotator Cuff Tears of the Shoulder, Labrum Injury
Lok™ Suture Anchors Safety & Performance Trial
The aim of this study is to evaluate the performance and safety of Move-Up's lok™ system (lok™ suture anchors range and associated instrumentation).
- Trial name
- NCT07448584
- Testing
- Rotator cuff lesions repair combined to a long head of biceps pathology, PASTA lesion, Shoulder instability repair
- Where
- France
- Volunteers
- 216 people
- Sponsor
- Move Up SAS
Obesity
Transoral Gastric Volume Reduction as an Intervention for Weight Management
The purpose of this study is to evaluate the safety, technical feasibility, and initial effectiveness (i.e., weight loss primarily measured as percent excess weight loss) of TGVR performed using the Bard RESTORe Suturing System
- Trial name
- TRIM (NCT00679848)
- Testing
- RS2 (RESTORe Suturing System)
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- C. R. Bard
Vascular Closure
Cross-Seal Closure Device IDE Trial - Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System
This study evaluates the safety and effectiveness of the Cross-Seal vascular closure device in gaining post procedure hemostasis in subjects undergoing interventional procedures requiring an 8 to 18 french size introducer sheath.
- Trial name
- NCT03756558
- Testing
- Cross-Seal System
- Where
- 20 sites in United States
- Volunteers
- 147 people
- Sponsor
- Terumo Medical Corporation
Wrinkles, Anti Aging
PER-SAF_PDOS (Performance and Safety of Polydioxanone Suture)
This clinical investigation aims to confirm the safety and efficacy of the ID in facial soft tissue reconstruction, specifically for non-incision surgery to tighten and lift the facial skin for a rejuvenated facial appearance.
- Conditions
- Wrinkles, Anti Aging, Face-lift
- Trial name
- PER-SAF_PDOS (NCT07068061)
- Testing
- PDO suture
- Volunteers
- 50 people
- Sponsor
- 21 Century Medical Co., Ltd.
Hallux Valgus Repairs, Medial or Lateral Instability Repairs/Reconstructions
A Study of the Safety and Performance of the MINITAC◊ Titanium 2.0 Suture Anchor
This is a retrospective study evaluating the safety and performance of the MINITAC Suture anchors for extremities repair. Data will be used to support Notified Body (BSI) requirements for extremities repair indications.
- Conditions
- Hallux Valgus Repairs, Medial or Lateral Instability Repairs/Reconstructions, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions
- Trial name
- MINITAC (NCT04186481)
- Testing
- MINITAC Ti 2.0 suture anchor
- Where
- Australia
- Volunteers
- 32 people
- Sponsor
- Smith & Nephew, Inc.
Percutaneous Intervention Via Common Femoral Vein
Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures
The purpose of this study is to evaluate the effectiveness and safety of the suture-mediated closure system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. following Percutaneous Common Femoral Vein Procedures.
- Trial name
- NCT07554976
- Testing
- SPIDER, Perclose ProGlide
- Where
- China
- Volunteers
- 136 people
- Sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTD