Clinical trials: Surgical Procedures, Operative
Patients Undergoing Clean Surgery
OPSITE Post-Op Visible Wound Dressings in Treatment of Surgical Incisions
OPSITE Post-Op Visible is a tri-layer dressing made up of a low adherent wound contact layer, lattice shaped absorbent pad and a top film that is waterproof and a bacterial barrier and is coated with a water-based adhesive.
- Trial name
- OPOV (NCT01577225)
- Testing
- OPSITE POST-OP VISIBLE, Tape and Gauze
- Where
- 6 sites in China
- Volunteers
- 100 people
- Sponsor
- Smith & Nephew Medical (Shanghai) Ltd
Obesity
Multi-Center Pre-Bariatric Weight Loss Study
The purpose of the study is to evaluate the safety and efficacy of the GI Sleeve in patients who require weight loss prior to their Bariatric surgery.
- Trial name
- NCT00469391
- Testing
- GI Sleeve Implantable weight loss device (EndoBarrier)
- Where
- 4 sites in United States
- Volunteers
- 56 people
- Sponsor
- Morphic Medical Inc.
Traumatic Lacerations or Surgical Incisions
Safety and Efficacy Study of BondEase to Treat Traumatic Lacerations and Surgical Incisions
To demonstrate that BondEase™ and conventional wound closure devices (CWCD) are the same in terms of cosmesis (appearance) of the repaired wound when these devices are used for closure of surgical and traumatic wounds .
- Trial name
- NCT01716013
- Testing
- BondEase, CWCD
- Where
- 6 sites in United States
- Volunteers
- 162 people
- Sponsor
- OptMed, Inc.
Mandibular Fractures, Facial Fracture
Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up
A retrospective post market follow up to confirm safety and performance of Stryker's Facial iD Universal Plate Configurator (UPC) implants in the clinical setting.
- Conditions
- Mandibular Fractures, Facial Fracture, Maxilla Fracture, Orthognathic Surgical Procedures
- Trial name
- UPC (NCT07245810)
- Testing
- Orthognatic surgery, Reconstructive maxillofacial surgery, Mandible and maxillofacial trauma surgery
- Where
- 2 sites in United States
- Volunteers
- 726 people
- Sponsor
- Stryker Craniomaxillofacial
Abdominal Aortic Aneurysm
Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA)
The objective of this study is to assess the safety and effectiveness of the Cordis Bilateral AAA device and its Delivery System compared to open surgical repair for the treatment of Abdominal Aortic Aneurysm (AAA).
- Trial name
- NCT00235118
- Testing
- Cordis AAA Bilateral Device
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Cordis US Corp.
Keloid, Surgical Scar
Safety and Efficacy of Infrared Diode Laser on Improvement of Scar and Prevention of Recurrence of Excised Keloid
A pilot study will be conducted on 2 type of subjects, one with plastic surgery scar with a randomization of laser treated portions, and other with keloid excision scar with a complete laser treatment.
- Trial name
- NCT01158196
- Testing
- infra-red diode laser
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Ekkyo
Early-Stage Non-Small Cell Lung Cancer
A Study to Assess The Safety and Tolerability of Pumitamig-Based Therapy Administered Before Surgery in Participants With Early-Stage Non-Small Cell Lung Cancer (ROSETTA Lung-220)
The purpose of this study is to assess the safety, tolerability, and surgical feasibility of preoperative Pumitamig-based therapy and other molecules in resectable, Early-Stage Non-Small Cell Lung Cancer
- Trial name
- NCT07871214
- Testing
- Pumitamig, Carboplatin, Cisplatin
- Where
- 50 sites in United States, Australia and 12 more
- Volunteers
- 80 people
- Sponsor
- Bristol-Myers Squibb
Post Surgical Ocular Inflammation and Pain
Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
The primary objective of the study is to investigate the efficacy and safety of KPI-121 1.0% ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.
- Trial name
- NCT02793817
- Testing
- KPI-121 1% Ophthalmic Suspension dosed BID, Vehicle of KPI-121 Ophthalmic Suspension dosed BID
- Where
- 35 sites in United States
- Volunteers
- 520 people
- Sponsor
- Kala Pharmaceuticals, Inc.
Mitral Valve Regurgitation
Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study
Evaluation of the technical feasibility and safety of the Mitral Adjustable Annuloplasty Ring.
- Trial name
- MAARS (NCT00554151)
- Testing
- Adjustable Annuloplasty Ring
- Where
- 5 sites in Germany, Italy and 1 more
- Volunteers
- 55 people
- Sponsor
- Abbott Medical Devices
Full-thickness Skin Defects, Degloving Injuries
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.
- Conditions
- Full-thickness Skin Defects, Degloving Injuries, Crush Injuries, Laceration of Skin
- Trial name
- NCT04091672
- Testing
- Control Intervention (Conventional Autograft), Investigational Intervention (RECELL + more widely meshed autograft)
- Where
- 18 sites in United States
- Volunteers
- 65 people
- Sponsor
- Avita Medical
Acute Major Bleeding, Reversal of Coagulopathy
Study of a Prothrombin Complex Concentrate for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Japanese Subjects
The purpose of this study is to evaluate efficacy and safety of a Prothrombin Complex Concentrate (PCC), BE1116. BE1116 will be used for the rapid reversal of coagulopathy induced by vitamin K antagonists in Japanese subjects who…
- Trial name
- NCT02281201
- Testing
- BE1116 (Prothrombin Complex Concentrate)
- Where
- 11 sites in Japan
- Volunteers
- 11 people
- Sponsor
- CSL Behring
Symptomatic Severe Aortic Stenosis
Portico Next Generation Approval Study
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the…
- Trial name
- NCT04011722
- Testing
- Portico™ NG (Navitor) Valve and FlexNav™ Delivery System, Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
- Where
- 28 sites in United States, Australia and 3 more
- Volunteers
- 333 people
- Sponsor
- Abbott Medical Devices
Ocular Infection
A Phase 2, Open-Label, Randomized, Parallel Group, Placebo-Controlled, Single-Center Study to Assess Anti-microbial Efficacy and Safety of DCN01 Compared to Unisol® Following Topical Periocular Administration in Healthy Volunteers
This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.
- Trial name
- NCT01853722
- Testing
- DCN01, Unisol
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Deacon Biosciences, Inc.
Dental Pain
Study of Diclofenac Capsules to Treat Dental Pain
The purpose of this study is to determine whether Diclofenac Test Formulation Capsules are safe and effective for the treatment of dental pain.
- Trial name
- NCT00985439
- Testing
- Diclofenac Test (lower dose), Diclofenac Test (upper dose), Celecoxib 400 mg
- Where
- United States
- Volunteers
- 202 people
- Sponsor
- Iroko Pharmaceuticals, LLC
Complication of Surgical Procedure
TCOT Effectiveness in Preventing Wound Infections in Perineal Resections
In colorectal surgery, oxygen insufflation (which leads to higher oxygen concentration in the surgical site) has been shown to decrease infection rate.
- Trial name
- NCT02374294
- Testing
- Epiflo
- Sponsor
- Neogenix, LLC dba Ogenix
Mitral Valve Regurgitation
Mi-thos® Transcatheter Mitral Valve Replacement(First-in-Man Study)
To evaluate the effectiveness and safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in the treatment of patients with moderate or greater mitral regurgitation who are at high risk for conventional surgery, or…
- Trial name
- NCT05784337
- Testing
- Mi-thos® Transcatheter Mitral Valve Replacement System
- Where
- 2 sites in China
- Volunteers
- 11 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Opioid Use Disorder
SafeMedWaste At-Home, Environmentally-Friendly Opioid Disposal Kit for Orthopedic Post-Operative Surgical Patients to Reduce Opioids Available for Diversion
There is an urgent unmet medical need for a cost-effective, environmentally friendly, in-home opioid disposal solution for surgical patients that is clinically proven to reduce opioid use disorder that is substantiated with…
- Trial name
- Drug Disposal (NCT06215170)
- Testing
- SafeMedWaste
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- SafeMedWaste, Inc.
Tendon Injuries
Adaprev in Digital Flexor Tendon Repair
This study is being undertaken to verify the safety and performance of Adaprev™, a Class III medical device, when administered as a short term implant into the tendon sheath at the time of surgery, on the post-operative function…
- Trial name
- NCT01014494
- Testing
- Adaprev
- Where
- 9 sites in United Kingdom
- Volunteers
- 44 people
- Sponsor
- Renovo
Anesthesia, Surgical Procedures, Elective
A Safety and Efficacy Study of Dexmedetomidine in Patients Requiring Sedation During Monitored Anesthesia Care (MAC)
The objective of this study is to evaluate the safety and efficacy of dexmedetomidine as compared to placebo when used for the sedation of subjects requiring monitored anesthesia care (MAC).
- Trial name
- NCT00398827
- Testing
- Dexmedetomidine
- Where
- 27 sites in United States
- Volunteers
- 326 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
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.