Clinical trials: Upper Limb Surgery
Cataract
Evaluation of 3 Intraocular Lenses Following Lens Extraction
The objective of this study is to evaluate the efficacy and subject satisfaction with three different FDA approved lenses for adults over 40 years of age who desire a reduction in spectacle dependence.
- Trial name
- NCT01122576
- Testing
- Crystalens AO, ReSTOR, Tecnis Multifocal IOL
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Bausch & Lomb Incorporated
Aortic Stenosis, Aortic Stenosis, Severe
PARTNER 3 Trial - Aortic Valve-in-Valve
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
- Trial name
- NCT03003299
- Testing
- Edwards SAPIEN 3/SAPIEN 3 Ultra THV
- Where
- 51 sites in United States, Canada
- Volunteers
- 125 people
- Sponsor
- Edwards Lifesciences
Liver Transplant Surgery, Liver Transplantation
Open Label Trial of Deceased Donor Livers Transplanted After DHOPE With eXVIVO LIVER Perfusion
The purpose of this clinical study is to confirm the safety and effectiveness of dual hypothermic oxygenated perfusion (DHOPE) using the Liver Assist to preserve deceased donor livers for transplantation.
- Trial name
- NCT06916325
- Testing
- dual hypothermic oxygenated perfusion (DHOPE)
- Volunteers
- 215 people
- Sponsor
- XVIVO Perfusion
Surgical Site Infection, Colon Surgery
D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)
Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), Compared to a SoC Treated…
- Conditions
- Surgical Site Infection, Colon Surgery, Abdominal Surgery, Post-Op Infection
- Trial name
- D-PLEX312 (NCT04411199)
- Testing
- D-PLEX, Standard of Care (SoC)
- Where
- 58 sites in United States, Bosnia and Herzegovina and 11 more
- Volunteers
- 975 people
- Sponsor
- PolyPid Ltd.
Biliary Tract Cancer
Study of Surufatinib as Second-line Treatment in Patients With Biliary Tract Carcinoma
A phase II, single-arm, open-label, multicenter study to assess the efficacy and safety of Surufatinib as a second-line treatment in patients with surgically unresectable or metastatic biliary tract carcinoma
- Trial name
- NCT02966821
- Testing
- Surufatinib
- Where
- 5 sites in China
- Volunteers
- 39 people
- Sponsor
- Hutchison Medipharma Limited
Plastic Surgery Procedures
Safety and Feasibility of the MACS in Surgical Procedures: A Prospective Multi-Center Study
The goal of this clinical trial is to evaluate the safety and performance of the MACS device in adults undergoing elective plastic surgery procedures.
- Trial name
- NCT07470411
- Testing
- MACS System
- Where
- Chile
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Levita Magnetics
Pelvic Organ Prolapse
Prospective Long-term Evaluation of the Efficacy and Safety of Calistar S for Transvaginal Pelvic Organ Prolapse Repair
Prospective long-term evaluation of the performance and safety of Calistar S for transvaginal pelvic organ prolapse repair in women with anterior POP with or without apical vaginal involvement
- Trial name
- CASPO (NCT03821142)
- Testing
- Transvaginal mesh for anterior pelvic organ prolapse repair
- Where
- 6 sites in Germany
- Volunteers
- 180 people
- Sponsor
- Promedon
Blood Loss, Surgical, Postoperative Hemorrhage
Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery
The objective of this study is to evaluate the safety and efficacy of aprotinin as compared to placebo, in reducing the need for blood transfusion in adult subjects undergoing elective spinal fusion surgery involving 3 to 7…
- Trial name
- NCT00327379
- Testing
- Trasylol (Aprotinin, BAYA0128)
- Where
- 14 sites in Canada, Germany and 1 more
- Volunteers
- 54 people
- Sponsor
- Bayer
Vascular Anastomosis Surgery
Post-market Clinical Study to Confirm Safety and Performance of PuraStat® for the Management of Bleeding in Vascular Surgery.
The objective of this post-market clinical follow-up study is to collect medical information on patients implanted with PuraStat®, according to each participating institution's procedures and standards of care.
- Trial name
- NCT03103282
- Testing
- PuraStat®
- Where
- United Kingdom
- Volunteers
- 65 people
- Sponsor
- 3-D Matrix Europe SAS
Hemorrhage, Urgent Surgery
Bentracimab in Ticagrelor-treated Patients With Uncontrolled Bleeding or Requiring Urgent Surgery or Invasive Procedure
This is a multi-center, open-label, prospective single-arm study of reversal of the antiplatelet effects of ticagrelor with bentracimab (PB2452) in patients who present with uncontrolled major or life-threatening bleeding or who…
- Conditions
- Hemorrhage, Urgent Surgery, Invasive Procedure
- Trial name
- REVERSE-IT (NCT04286438)
- Testing
- Bentracimab (PB2452) Infusion
- Where
- 68 sites in United States, Austria and 11 more
- Volunteers
- 226 people
- Sponsor
- SFJ Pharmaceuticals, Inc.
Full- Thickness Massive RCT (MRCT) of at Least 5 cm in Diameter Including Fatty Infiltration Grade III or IV
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear.
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .
- Trial name
- NCT01890733
- Testing
- Best Repair of torn Rotator Cuff, InSpace™ system
- Where
- Italy
- Volunteers
- 5 people
- Sponsor
- OrthoSpace Ltd.
Surgery
Maestro LIFT-OFF: Surgical Assistance Device in Abdominal Laparoscopic Surgery
The objective of the study is to provide evidence for the safety and effectiveness of the Maestro Platform for surgical assistance in abdominal laparoscopic surgery.
- Trial name
- Maestro (NCT05243433)
- Testing
- Laparoscopic surgery using the Maestro Platform
- Where
- Belgium
- Volunteers
- 50 people
- Sponsor
- Moon Surgical
Breast Cancer Female
Wide-field Optical Coherence Tomography Imaging of Excised Breast Tissue.
This is a single-arm, multi-center data collection study designed to collect WF-OCT imaging data of excised breast tissue margins with corresponding margin status from histopathology.
- Trial name
- NCT04242277
- Testing
- Investigational WF-OCT device
- Where
- 2 sites in United States
- Volunteers
- 198 people
- Sponsor
- Perimeter Medical Imaging
Blood Loss, Surgical
Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement
The purpose of this study is to assess if aprotinin (BAY A0128), given intravenously during surgery, is safe and can help reduce the amount of bleeding and the need for a blood transfusion during hip replacement surgery.
- Trial name
- NCT00668031
- Testing
- Trasylol (Aprotinin, BAYA0128)
- Where
- 40 sites in United States, Canada and 1 more
- Volunteers
- 359 people
- Sponsor
- Bayer
Venous Thromboembolism
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery
The primary objective was to demonstrate the dose-response of Semuloparin sodium (AVE5026) for the prevention of Venous Thromboembolism [VTE] in patients undergoing total knee replacement [TKR] surgery.
- Trial name
- TREK (NCT00331838)
- Testing
- Semuloparin sodium, Enoxaparin sodium
- Where
- 19 sites in Argentina, Bulgaria and 17 more
- Volunteers
- 705 people
- Sponsor
- Sanofi
Bone Substitutes, Bone Defect
Pre-market Study to Evaluate Safety and Performance of GreenBone Implant (Long Bone Study)
Multi-center, international, prospective, open-label, single-arm, first-in-human clinical investigation. The Patients enrolled in this clinical investigation will undergo a scheduled surgery for the treatment of long bone defects…
- Trial name
- NCT03884790
- Testing
- surgical repair of long bone defects
- Where
- 8 sites in Bosnia and Herzegovina, Israel and 4 more
- Volunteers
- 16 people
- Sponsor
- GreenBone Ortho S.p.A.
Arthroplasty Replacement, Knee, Arthroplasty Total Hip Replacement
A Prospective, Single-arm, Trial to Determine Contamination Rates When Using an Antibacterial Incise Drape During Orthopedic Surgery
The goal of this clinical study is to generate data on the intended use of a chlorhexidine gluconate (CHG)-impregnated antimicrobial incise drape.
- Trial name
- NCT07356323
- Testing
- 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (2% w/w CHG)
- Where
- 2 sites in United States
- Volunteers
- 179 people
- Sponsor
- Solventum US LLC
Mitral Stenosis With Insufficiency, Functional Mitral Regurgitation
AVJ-514 Japan Trial
The objective of the study is to confirm the reproducibility of the evidence of safety and efficacy of AVJ-514 System technology in Japanese subjects who have been deemed difficult for mitral valve surgery by the local site heart…
- Conditions
- Mitral Stenosis With Insufficiency, Functional Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence
- Trial name
- NCT02520310
- Testing
- AVJ-514
- Where
- 6 sites in Japan
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Epithelial Ovarian Cancer, Fallopian Tube Cancer
A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of neoadjuvant carboplatin and mirvetuximab soravtansine in…
- Conditions
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Neoadjuvant
- Trial name
- NCT06890338
- Testing
- Carboplatin, Mirvetuximab Soravtansine, Bevacizumab
- Where
- 73 sites in United States
- Volunteers
- 140 people
- Sponsor
- AbbVie
Surgical Site Infection, Colon Surgery
D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), compared to a SoC treated…
- Conditions
- Surgical Site Infection, Colon Surgery, Abdominal Surgery, Post-Op Infection
- Trial name
- NCT04233424
- Testing
- D-PLEX, Standard of Care (SoC)
- Where
- 62 sites in United States, Bulgaria and 8 more
- Volunteers
- 977 people
- Sponsor
- PolyPid Ltd.