Clinical trials: Surgical Procedure, Operative
- Condition Surgical Procedure, Operative
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Fecal Incontinence
Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence
The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.
- Trial name
- TRANSFORM (NCT01090739)
- Testing
- TOPAS Treatment for Fecal Incontinence
- Where
- 14 sites in United States
- Volunteers
- 207 people
- Sponsor
- ASTORA Women's Health
Ventral Hernia
Hernia Repair in Multiply Morbid Patients
Support of a ventral hernia repair with a prosthetic mesh has been demonstrated to result in a diminished rate of hernia recurrence.
- Trial name
- RAM2P (NCT00930787)
- Testing
- Strattice Reconstructive Tissue Matrix (Hernia Repair), Proceed Surgical Mesh (Hernia repair)
- Where
- 13 sites in United States
- Volunteers
- 23 people
- Sponsor
- LifeCell
Surgical Site Reaction
The Use of the Prevena Incision Management System (PIMS) on Closed Incisions in Renal Transplant Subjects
This study is being conducted to see how safe and effective the Prevena Incision Management System "Prevena" is when placed over a renal transplantation incision. Prevena provides negative pressure (suction) wound therapy.
- Trial name
- PIMS (NCT01341444)
- Testing
- Prevena Incision Management System, Standard of Care for Surgical Incisions
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- KCI USA, Inc
Bariatric Surgery Candidate, Cholelithiases
Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures
The purpose of this study is to evaluate the safety and feasibility of the Levita Dual Robotic Arm Accessory (DRAA) used with the Levita Magnetic Surgical System (MSS)
- Conditions
- Bariatric Surgery Candidate, Cholelithiases, Other Disease
- Trial name
- MARS GI (NCT05695989)
- Testing
- Dual Robotic Arm Accessory (DRAA)
- Where
- 3 sites in Chile
- Volunteers
- 22 people
- Sponsor
- Levita Magnetics
Infections
Pharmacokinetics and Safety of Cefazolin 3gm DUPLEX in Adults
This study is designed to evaluate the pharmacokinetics (PK) of a single 3 gm dose of cefazolin from a DUPLEX container, in adult subjects (weighing >/= 120 kg) scheduled for surgery.
- Trial name
- 3gCefPK (NCT05205486)
- Testing
- Cefazolin 3gm for Injection USP and Dextrose Injection USP
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- B. Braun Medical Inc.
Abscess, Wound Infection
Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in participants with known or suspected…
- Conditions
- Abscess, Wound Infection, Surgical Site Infection, Cellulitis
- Trial name
- NCT02127970
- Testing
- Dalbavancin
- Where
- 78 sites in United States, Bulgaria and 10 more
- Volunteers
- 698 people
- Sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plc
Intraoperative Bleeding
Adjunctive Application of BioFoam Surgical Matrix in Liver Surgery
This is a prospective, multicenter, randomized, controlled investigation. Subjects in which bleeding from the exposed parenchymal surface is observed intraoperatively following the ligature of vessels visible with the unaided eye…
- Trial name
- BARRIER (NCT01458561)
- Testing
- BioFoam Surgical Matrix, Gelfoam Plus
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- CryoLife, Inc.
Post Ocular Surgical Inflammation and Pain
Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who have undergone…
- Trial name
- NCT02034019
- Testing
- Dexamethasone, Punctum Plug
- Where
- United States
- Volunteers
- 247 people
- Sponsor
- Ocular Therapeutix, Inc.
Type 2 Diabetes, Obesity
Study for Pre-Surgical Weight Loss in Type II Diabetes Patients
The purpose of this study is to determine whether the GI Sleeve is safe and effective in treating Type II diabetes patients
- Trial name
- NCT00791128
- Testing
- GI Liner
- Where
- Brazil
- Volunteers
- 22 people
- Sponsor
- Morphic Medical Inc.
Symptomatic Neuroma, Morton's Neuroma
Study of AxoGuard® Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma & Prevention of Recurrent Neuroma Pain
Comparing safety, pain, user experience, healthcare economic costs, work productivity, impairment and quality of life outcomes between Axoguard® Nerve Cap and neurectomy in the treatment of symptomatic neuromas in the foot or…
- Conditions
- Symptomatic Neuroma, Morton's Neuroma, Chronic Nerve Pain
- Trial name
- REPOSE (NCT03940963)
- Testing
- AxoGuard® Nerve Cap, Standard Neurectomy
- Where
- 11 sites in United States
- Volunteers
- 86 people
- Sponsor
- Axogen Corporation
Anesthesia Induced Hypothermia, Inadvertent Perioperative Hypothermia
Study to Evaluate Safety and Efficacy of Blanket Used to Prevent Anesthesia Induced Hypothermia
The investigation was designed as an Open-Label, Multicenter, Randomised, Controlled Investigation to Evaluate the Efficacy and Safety of the BARRIER® EasyWarm Active Self-Warming Blanket Used for Continuous Active Warming to…
- Trial name
- NCT01900067
- Testing
- BARRIER® EasyWarm Active Self-Warming Blanket
- Volunteers
- 271 people
- Sponsor
- Molnlycke Health Care AB
Bladder Cancer
Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)
The purpose of this study was to evaluate the 2-Year Recurrence Rate of bladder cancer in randomized patients with tumor histology Ta, G1-G2 who received TransUrethral Resection of Bladder Tumor (TURBT) plus apaziquone versus…
- Trial name
- NCT00598806
- Testing
- Apaziquone, TURBT
- Where
- 77 sites in United States, Canada and 1 more
- Volunteers
- 812 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Primary Lung Cancer, Benign Lung Disease
SP Thoracic IDE Study
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in pulmonary lobectomy, and in thymectomy procedures.
- Conditions
- Primary Lung Cancer, Benign Lung Disease, Thymoma, Myasthenia Gravis
- Trial name
- NCT05150210
- Testing
- Robotic-Assisted Surgery
- Where
- 6 sites in United States
- Volunteers
- 32 people
- Sponsor
- Intuitive Surgical
Obesity
Reinforcement of Surgical Staple Lines Using Peri-Strips Dry (PSD) With Veritas Collagen Matrix
The purpose of this study is to verify the performance of PSD Veritas to provide staple line protection during surgical procedures for obesity.
- Trial name
- RESULTS (NCT00566943)
- Testing
- PSD Veritas Collagen Matrix, Roux-en-Y gastric by-pass surgery with no buttress
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Baxter Healthcare Corporation
Colorectal Procedures
Study of Colorectal Procedures With the Levita Magnetic Surgical System
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing colorectal procedures.
- Trial name
- NCT03960684
- Testing
- Levita Magnetic Surgical System
- Where
- Chile
- Volunteers
- 31 people
- Sponsor
- Levita Magnetics
Soft Tissue Surgical Bleeding
Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Soft Tissue Open Surgeries
This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in patients undergoing elective (non-emergency) soft tissue open surgery where bleeding may be present.
- Trial name
- NCT01731938
- Testing
- Fibrin Sealant (FS) Grifols, Surgicel®
- Where
- 25 sites in United States, Hungary and 1 more
- Volunteers
- 327 people
- Sponsor
- Grifols Biologicals, LLC
Knee Pain Chronic, Arthritis (Hip)
Supporting Decision Making for Musculoskeletal Preference-Sensitive Care
The purpose of this study is to compare condition oriented whole person Health Coaching along with the provision of decision aids to decision aids without condition oriented Health Coaching to neither condition oriented health…
- Conditions
- Knee Pain Chronic, Arthritis (Hip), Arthritis (Knee), Back Pain
- Trial name
- NCT01345123
- Testing
- Provision of condition specific shared decision making (SDM) aids only, Telephonic outreach and support by Health Coach
- Where
- United States
- Volunteers
- 9,925 people, healthy volunteers welcome
- Sponsor
- Health Dialog
Bloodloss, Surgical Procedures, Operative
Outcomes and Safety Trial Investigating Ecallantide's Effect on Reducing Surgical Blood Loss Volume in Subjects at High Risk of Bleeding Exposed to Cardio-pulmonary Bypass During Cardiac Surgery
A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding
- Trial name
- CONSERV-2 (NCT00888940)
- Testing
- Ecallantide, Cyklokapron(R)
- Where
- 34 sites in United States, Germany and 1 more
- Volunteers
- 243 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site
Safety and Efficacy of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery.
This study is aimed to assess the anti-infective efficacy of D-PLEX over a period of 3 months post operation as well as the safety over a period of 6 months, by preventing sternal infection post cardiac surgery in patients above…
- Trial name
- NCT02731573
- Testing
- D-PLEX, Open heart surgery
- Where
- 5 sites in Israel
- Volunteers
- 81 people
- Sponsor
- PolyPid Ltd.
Hemophilia
Safety and Efficacy of FVIIa to Prevent Excessive Bleeding in Hemophilia Patients With Inhibitors Undergoing Major Surgery
This is an interventional, prospective, international, multicenter, single-arm, Phase 3, and sequential efficacy and safety study in adolescents and adults with congenital hemophilia A or B with inhibitors to factor VIII (FVIII)…
- Trial name
- SCOPE HIM (NCT05695391)
- Testing
- Coagulation Factor VIIa (Recombinant)
- Where
- 15 sites in United States, Malaysia and 4 more
- Volunteers
- 2 people
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies