Clinical trials: Sutures
Breast Cancer Female
Effect of Quilting Sutures on Post-operative Drainage After Mastectomy and/or Axillary Lymph Node Dissection
Breast cancer is the most frequent type of cancer among Swiss women (5'700 cases diagnosed every year). Mastectomy is indicated when breast conservative surgery is not possible or by patient wish.
- Trial name
- Quilting (NCT03902977)
- Testing
- quilting, conventional suture
- Where
- Switzerland
- Volunteers
- 10 people
- Sponsor
- Lindenhofgruppe AG
Polyps
Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy
The purpose of this study is to show that the surgical site in the bowel wall can be sewn closed in the colon or intestine, with a new sewing device after removal of a benign polyp according to standard of care.
- Trial name
- NCT00553436
- Testing
- Tissue Apposition System (TAS) Device
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Ethicon Endo-Surgery
Rotator Cuff
Safety of Treatment of Shoulder Repair
This study evaluates the safety of the HEALICOIL Knotless Suture Anchors in patients requiring a repair of the rotator cuff tendon repair
- Trial name
- HEALICOIL_KNTL (NCT04552119)
- Testing
- HEALICOIL Knotless PEEK, HEALICOIL Knotless REGENESORB
- Where
- 5 sites in United States
- Volunteers
- 138 people
- Sponsor
- Smith & Nephew, Inc.
Arthroscopy
A Clinical Study to Evaluate the Safety and Efficacy of Q-Fix Trial in Chinese Patients
Protocol synopsis Title of Study: A Prospective, Randomized, Multi-Center Clinical Study to Evaluate the Safety and Efficacy of Q-Fix All-Suture Anchor in Arthroscopic Repair of Shoulder Soft Tissue in Chinese Patients Study…
- Trial name
- Q-Fix (NCT03765515)
- Testing
- Twinfix Ti, Q-Fix
- Where
- 4 sites in China
- Volunteers
- 128 people
- Sponsor
- Smith & Nephew, Inc.
Sutures
A Study of Two Types of Absorbable Surgical Sutures in the Suturing of Thyroid Surgery Incision
The primary objective of this study is to evaluate the efficacy and safety of two types of absorbable surgical sutures -- STRATAFIX Spiral PDS Knotless Plus Tissue Control Device and STRATAFIX Spiral MONOCRYL Plus Knotless Tissue…
- Trial name
- Nautilus (NCT03792737)
- Testing
- Spiral PDS Plus, Spiral MONOCRYL Plus, PDS Plus
- Where
- 10 sites in China
- Volunteers
- 501 people
- Sponsor
- Ethicon, Inc.
Pelvic Organ Prolapse, Genital Prolapse
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
The purpose of the clinical investigation is to generate clinical data to substantiate the safety and performance of the i-Stitch device for bilateral sacrospinous ligament fixation (SSLF) in pelvic organ prolapse (POP) repair.
- Trial name
- i-StitchSSLF (NCT06805006)
- Testing
- SSLF
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Mitral Valve Regurgitation
Safety and Performance Study of the NeoChord Device
The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000 Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in patients with mitral regurgitation.
- Trial name
- TACT (NCT01777815)
- Testing
- NeoChord DS1000 Artificial Chordae Delivery System
- Where
- 8 sites in Denmark, Germany and 2 more
- Volunteers
- 30 people
- Sponsor
- NeoChord
Surgical Incisions
LiquiBand Versus Dermabond Versus Sutures for Closure of Surgical Wounds
To evaluate the cosmetic outcome, effectiveness, user and subject satisfaction, and safety of LiquiBand® Flex in relation to DermaBond Advanced™ and conventional sutures for the topical closure of surgical wounds.
- Trial name
- NCT01835405
- Testing
- LiquiBand Flex, Dermabond Advanced, Sutures (Prolene)
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Advanced Medical Solutions Ltd.
Atrial Fibrillation
aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an…
- Trial name
- aMAZE (NCT02513797)
- Testing
- LARIAT + PVI, Pulmonary Vein Isolation
- Where
- 53 sites in United States
- Volunteers
- 600 people
- Sponsor
- AtriCure, Inc.
Appendicitis, Cholecystitis
NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy
The aim of this study is to evaluate if the application of a Chlorhexidine coated suture (Novosyn® CHD) will reduce the colonization of bacteria in comparison to an uncoated suture (Novosyn®) used for the closure of trocar wounds…
- Trial name
- NOVOTILAC (NCT04033211)
- Testing
- Novosyn® CHD for fascia and skin closure, Novosyn® for fascia and skin closure
- Where
- 4 sites in Germany, Spain
- Volunteers
- 316 people
- Sponsor
- Aesculap AG
Instability, Joint
Safety and Performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in Shoulder and Hip Arthroscopic Repair
The scientific justification is to fulfill post-market clinical requirements in order to support re-certification of the CE-Mark for this marketed product and to look into safety and efficacy.
- Trial name
- NCT03691298
- Testing
- SUTUREFIX ULTRA Suture Anchor and SUTUREFIX CURVED Suture Anchor
- Where
- 9 sites in United States, Denmark and 4 more
- Volunteers
- 83 people
- Sponsor
- Smith & Nephew Orthopaedics AG
Mitral Valve Regurgitation, Mitral Valve Prolapse
CE Mark Study for the Harpoon Medical Device in Poland
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant advantages over current surgical interventions including: 1) a small minimally…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- NCT02432196
- Testing
- Harpoon Medical Device
- Where
- 2 sites in Poland
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Abnormal Uterine Bleeding, Endometriosis
Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy
The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic…
- Conditions
- Abnormal Uterine Bleeding, Endometriosis, Uterine Prolapse, Uterine Cancer
- Trial name
- BARHYSTER (NCT06024109)
- Testing
- Closure of the Vaginal Cuff after Total Hysterectomy
- Where
- 2 sites in Germany, Spain
- Volunteers
- 132 people
- Sponsor
- Aesculap AG
Meniscal Tear, Meniscus Tear
Study of Suture Repair of Torn Meniscus in the Knee
Horizontal meniscus tears meeting specified criteria will be repaired by any commonly used suture technique. Subjects will be followed for 2 years to evaluate the effectiveness of the repair, by assessing the re-operation rate…
- Trial name
- STITCH (NCT02237001)
- Testing
- Suture-based meniscal repair
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- Smith & Nephew, Inc.
Ventral Hernia, Pain
Transfacial Sutures Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair
Hernia of the abdominal wall occur frequently after various surgical procedures of the abdomen and are increasingly performed by laparoscopic means.
- Trial name
- NCT00773851
- Testing
- mesh fixation by transfacial sutures, mesh fixation by staples
- Where
- Switzerland
- Volunteers
- 36 people
- Sponsor
- Medtronic - MITG
Laceration of Skin
Evaluation of Zip Device to Conventional Sutures for Laceration Repair in Pediatrics in an Emergency Department
A prospective, randomized, controlled post-market clinical investigation that will enroll pediatric subjects requiring laceration repair.
- Trial name
- ZIPPED (NCT04122859)
- Testing
- Zip Skin Closure Device
- Where
- Israel
- Volunteers
- 30 people
- Sponsor
- ZipLine Medical Inc.
Incisional Hernia, Incisional Hernia of Midline of Abdomen
Mesh Augmented Reinforcement of Abdominal Wall Suture Line to Limit the Rate of Incisional Hernia Occurrence
The purpose of this prospective, pivotal, multi-center, single-arm, pre-market, investigational clinical study is to assess the safety and performance of Deternia™ Self-Gripping Resorbable Mesh when used for suture line…
- Conditions
- Incisional Hernia, Incisional Hernia of Midline of Abdomen, Midline Laparotomy
- Trial name
- MARS (NCT05424484)
- Testing
- Self-Gripping Resorbable Mesh
- Where
- 13 sites in Croatia, Germany and 3 more
- Volunteers
- 123 people
- Sponsor
- Medtronic - MITG
Percutaneous Closure of Arteriotomy in Common Femoral Artery
Clinical Study of the Medeon Biodesign XPro™
To access the safety and performance of the XPro System to facilitate hemostasis in patients undergoing percutaneous endovascular procedures utilizing 8-18 Fr introducer sheath via the common femoral.
- Trial name
- NCT03171155
- Testing
- XPro System
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 28 people
- Sponsor
- Medeon Biodesign, Inc.
Laceration
A Randomized Post-market Study to Evaluate Zip Device Compared to Sutures for Laceration Repair in Pediatrics and Adults
The Zip-009 clinical investigation will enroll 26 paediatric and adult subjects requiring laceration repair and fulfilling the eligibility criteria for the clinical investigation.
- Trial name
- NCT03199456
- Testing
- Zip surgical skin closure device, Standard of Care sutures
- Where
- 2 sites in Sweden
- Volunteers
- 26 people
- Sponsor
- ZipLine Medical Inc.
Rotator Cuff Tear
Pilot Study of the Use of ULTRABRAID PLUS SUTURE in the Repair of Tears of the Rotator Cuff
The primary objective of this study is to obtain safety data on the use of the ULTRABRAID PLUS SUTURE, and to assess the preliminary effectiveness of the use of the ULTRABRAID PLUS SUTURE in comparison to the ULTRABRAID SUTURE in…
- Trial name
- NCT01767740
- Testing
- ULTRABRAID PLUS SUTURE, ULTRABRAID SUTURE
- Where
- 4 sites in Canada
- Volunteers
- 82 people
- Sponsor
- Smith & Nephew, Inc.