Clinical trials: Tear
Rotator Cuff Tear, Fatty Atrophy
Efficacy of an Amniotic Fluid Derived Allograft, (FlōGraft®) in Rotator Cuff Repairs: A Prospective Study
Rotator Cuff (RC) repair will be augmented with the injection of a human amniotic fluid derived allograft at the repair interface junction.
- Trial name
- NCT03379324
- Testing
- Superiority of augmented repairs, Fat degeneration of supraspinatus muscle
- Where
- United States
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- Applied Biologics, LLC
Dura Mater Nick Cut or Tear, Hemostatis
Hemopatch Performance Evaluation: A Prospective Observational Registry
To assess the clinical performance and safety of HEMOPATCH Sealing Hemostat in a post-marketing setting in cardiovascular, thoracic, urologic, neurological, and other general surgical procedures.
- Conditions
- Dura Mater Nick Cut or Tear, Hemostatis, Air Leakage, Body Fluid Leakage
- Trial name
- NCT03392662
- Testing
- Hemopatch
- Where
- 15 sites in Austria, Czechia and 3 more
- Volunteers
- 621 people
- Sponsor
- Baxter Healthcare Corporation
Contusions, Incision
Dermal Wound Closure Using Silkam®
Assessment of performance of Silkam® suture material for skin closure. A prospective, single center, single arm, observational study in daily practice.
- Conditions
- Contusions, Incision, Laceration
- Trial name
- DERMASILK (NCT05225714)
- Where
- Spain
- Volunteers
- 161 people
- Sponsor
- Aesculap AG
Anterior Cruciate Ligament Injuries
A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)
The purpose of the Bridge Registry is to assess real-world performance of the FDA approved BEAR Implant.
- Trial name
- NCT05398341
- Testing
- The BEAR® Implant
- Where
- 8 sites in United States
- Volunteers
- 300 people
- Sponsor
- Miach Orthopaedics
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.
Intrauterine Devices
Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs
Study to analyze electronic medical records of women using an intrauterine device (IUD). The study was required by the FDA for the marketed IUD Mirena (US Post-marketing requirement; short name of study: APEX IUD).
- Trial name
- APEX IUD (NCT03754556)
- Testing
- Intrauterine device
- Where
- 4 sites in United States
- Volunteers
- 326,658 people, healthy volunteers welcome
- Sponsor
- Bayer
White Blood Cells
Study of the Cell Response in the Tear Film After Overnight Contact Lens Wear
The purpose of this study was to count and analyze the white blood cells in tear samples collected from study participants following sleep.
- Trial name
- CORNWALL (NCT01379768)
- Testing
- Lotrafilcon A contact lens, Lotrafilcon B contact lens, Clear Care Cleaning and Disinfection Solution
- Where
- Canada
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- CIBA VISION
ACL Tears
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
This research study will evaluate mid-term clinical safety and performance outcomes of the BioBrace® Reinforced Implant when used to augment a tissue graft during anterior cruciate ligament (ACL) reconstruction.
- Trial name
- NCT06948591
- Testing
- Anterior cruciate ligament reconstruction with BioBrace® augmentation, Arthroscopic anterior cruciate ligament reconstruction
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- CONMED Corporation
Aortic Aneurysm, Thoracic, Descending Thoracic Aortic Dissection
Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases (VALIANT CAPTIVIA France)
The objective of this study is to assess the benefits of endovascular technique in terms of efficacy and safety of Valiant Thoracic Stent Graft with the Captivia Delivery System in the treatment of thoracic aortic disease, in a…
- Conditions
- Aortic Aneurysm, Thoracic, Descending Thoracic Aortic Dissection, Penetrating Ulcer, Aorta Thoracic; Traumatic Rupture
- Trial name
- NCT01775046
- Testing
- DTA patients (Valiant)
- Where
- 17 sites in France
- Volunteers
- 160 people
- Sponsor
- Medtronic Cardiovascular
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
Shoulder Pain, Shoulder Injuries
MDR SureLock All-Suture Anchor
To report the outcomes of a series of patients with recurrent anterior and/or posterior shoulder instability who underwent surgical repair of the affected labrum using the SureLock all-suture anchor.
- Conditions
- Shoulder Pain, Shoulder Injuries, Shoulder Disease, Shoulder Pain Chronic
- Trial name
- NCT04093700
- Testing
- SureLock All-Suture Anchor
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Zimmer Biomet
Wounds and Injuries, Lacerations
A Clinical Study to Compare MAR-CUTIS With Dermabond Advanced
This was a randomized, open-label, multicenter, comparator-controlled clinical study to compare MAR-CUTIS with Dermabond Advanced in closure of surgical incisions and lacerations less than or equal to (<=)15 centimeter (cm).
- Conditions
- Wounds and Injuries, Lacerations, Surgical Incision
- Trial name
- NCT03688880
- Testing
- MAR-CUTIS, Dermabond Advanced
- Where
- 19 sites in France, Germany and 2 more
- Volunteers
- 107 people
- Sponsor
- Grünenthal GmbH
Breast Augmentation
Long-Term Effectiveness of the Motiva Implants® Round and Round Ergonomix
Post-marketing surveillance study to demonstrate the silent rupture rate and satisfaction of patients who underwent a primary and revision breast augmentation surgery with Motiva Implants®, 3 to 10 years before enrollment.
- Trial name
- MIRO (NCT05449587)
- Testing
- MRI and PRO
- Where
- 2 sites in Costa Rica
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Motiva USA LLC
Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage
HEMOLEVEN® Expanded Access Program Prevention of Surgical/Postpartum Hemorrhage Severe Inherited Factor XI Deficiency
The objective of the Expanded Access Program is to provide HEMOLEVEN, a replacement coagulation factor XI, to patients with severe inherited factor XI deficiency where, in the opinion of the treating physician, the benefits of…
- Conditions
- Wound; Rupture, Surgery, Cesarean Section, Postpartum Hemorrhage, Surgery
- Trial name
- EAP (NCT01701947)
- Testing
- Hemoleven
- Where
- United States
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
ACL Tears
MRI Evaluation of Graft Maturation Following ACL Reconstruction
Post-surgical ACL Graft maturation will be assessed at 4.5, 6, 7.5, 9, 10.5, and 12 months with MRI.
- Trial name
- NCT07046000
- Testing
- MRI
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Skye Biologics Holdings, LLC
Ankle Injuries, Syndesmotic Injuries
Grappler® Interference Screw Post-Market Clinical Follow-Up Study
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.
- Conditions
- Ankle Injuries, Syndesmotic Injuries, Ankle Inversion Sprain, Deltoid Ankle Sprain
- Trial name
- NCT04893824
- Testing
- Grappler® Interference Screw System
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Paragon 28
Hip Labral Tear
Study of RNS60 on Pain and Function After Hip Labral Repair
The purpose of this study is to see if use of RNS60 during hip labral repair surgery decreases pain and improves functional capacity post-operation.
- Trial name
- NCT02005523
- Testing
- RNS60, Saline
- Where
- United States
- Sponsor
- Revalesio Corporation
Ankle Injuries, Syndesmotic Injuries
Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.
- Conditions
- Ankle Injuries, Syndesmotic Injuries, Ankle Inversion Sprain, Deltoid Ankle Sprain
- Trial name
- NCT05190874
- Testing
- Grappler Interference Screw System
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Paragon 28
Anterior Cruciate Ligament Tear
Bridge-Enhanced ACL Repair vs ACL Reconstruction
The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR™) technique with the current method of treatment for anterior cruciate ligament (ACL) injuries, ACL reconstruction.
- Trial name
- NCT02664545
- Testing
- BEAR Scaffold, Tendon Graft
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Miach Orthopaedics
Acute Conjunctivitis, Adenoviral Conjunctivitis
Evaluation of a Rapid Screening Test for Detection of Adenovirus in Tears
To compare the efficacy of a recently FDA approved point of care diagnostic test, the RPS Adeno Detector (Rapid Pathogen Screening, Inc.; South Williamsport, PA), against cell culture for detecting adenoviral conjunctivitis
- Trial name
- NCT00266734
- Testing
- RPS Adeno Detector
- Where
- 5 sites in United States, Germany
- Volunteers
- 186 people
- Sponsor
- Rapid Pathogen Screening