Clinical trials: Surgical Procedure, Operative
Atrial Fibrillation
nContactSurgical Numeris-AF Tethered Coagulation System for Treatment of Persistent & LSP AF
This is a multi center, non-randomized, prospective, open label, clinical trial evaluating the safety and efficacy of the nContact Surgical Numeris-AF Tethered Coagulation System when used to treat patients with persistent and…
- Trial name
- NCT00950092
- Testing
- Numeris-AF Tethered Coagulation System with VisiTrax
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- nContact Surgical Inc.
Acute Pain
Analgesic Efficacy and Safety of ADL5859 in Subjects With Acute Dental Pain After Third Molar Extraction
The objective of this study is to evaluate the analgesic efficacy and safety of ADL5859 compared with placebo and an active control (ibuprofen) in subjects with acute dental pain after third molar extraction.
- Trial name
- NCT00993863
- Testing
- ADL5859 30 mg, ADL5859 100 mg, ADL5859 200 mg
- Where
- United States
- Volunteers
- 201 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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
Cardiovascular Surgical Procedure
CardioRoot Post-Marketing Surveillance Registry
Post-marketing surveillance registry of the CardioRoot graft.
- Trial name
- CardioRoot (NCT01609270)
- Testing
- CardioRoot graft
- Where
- 6 sites in Czechia, France and 1 more
- Volunteers
- 52 people
- Sponsor
- Maquet Cardiovascular
Breast Cancer
Intraoperative Use of ClearEdge Device in Breast Conserving Surgery
Multi center, pivotal prospective, randomized clinical trial The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge imaging device to the Standard of Care (SoC) of margins assessment in breast…
- Trial name
- NCT05456373
- Testing
- ClearEdge device
- Where
- United States
- Volunteers
- 288 people
- Sponsor
- LS BioPath
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.
Aortic Stenosis, Aortic Insufficiency
First in Human Feasibility Study With ADAPT 3D - ALR for Aortic Leaflet Repair
This study will evaluate the safety and performance of the ADAPT 3D - ALR in adult patients requiring replacement of aortic valve. 15 patients in one site in Belgium will all be treated with ADAPT 3D - ALR.
- Trial name
- NCT04178213
- Testing
- Implantation of ADAPT 3D ALR
- Where
- Belgium
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
Retinal Detachment
Proof of Concept - Digital Electro-optical Surgical Platform as Replacement for Operational Microscopes
Evaluate the use of Elbit's digital electro-optical systems for generating detailed high quality video imaging during surgery, and thus improving the surgeon's visualization, performance and outcome.
- Trial name
- NCT02715388
- Testing
- GlasScope Surgical Microscope
- Where
- Israel
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Elbit Systems LTD
Earlobe Keloids
A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid Lesions Treated Adjunctive to Surgical Excision
The objective of the study is to actively gather additional information on safety, device performance and possible emergent risks following the use of Celotres in a post-market setting when used to reduce the recurrence rate…
- Trial name
- EURO KLEAR (NCT01706861)
- Testing
- Celotres
- Where
- 6 sites in Poland, The Bahamas and 1 more
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Halscion, Inc.
Transcatheter Aortic Valve Implantation
NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population
The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.
- Trial name
- FOLLOW (NCT03613246)
- Where
- 14 sites in Finland, Germany and 4 more
- Volunteers
- 346 people
- Sponsor
- NVT GmbH
Von Willebrand Disease, Blood Coagulation Disorders
Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)
The purpose of this study is to test the safety and effectiveness of Humate-P® to prevent bleeding in patients with von Willebrand Disease who are undergoing surgery.
- Conditions
- Von Willebrand Disease, Blood Coagulation Disorders, Blood Platelet Disorders, Hematologic Disease
- Trial name
- NCT00168090
- Testing
- Blood coagulation Factor VIII and vWF, human
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- CSL Behring
Anal High Grade Squamous Intraepithelial Lesion, Anal Precancerous Condition
Artesunate Suppositories for the Treatment of HIV-negative Patients With Intra-anal HSIL
This is a phase II double blind, placebo-controlled, randomized study of Artesunate suppositories for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL)
- Conditions
- Anal High Grade Squamous Intraepithelial Lesion, Anal Precancerous Condition, AIN 2/3, HPV Infection
- Trial name
- anal HSIL HIV- (NCT05555862)
- Testing
- Artesunate
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Frantz Viral Therapeutics, LLC
Transcatheter Aortic Valve Implantation
Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis
The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System.
- Trial name
- EMPIRE (NCT05478161)
- Testing
- (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 11 sites in Germany, Netherlands and 1 more
- Volunteers
- 137 people
- Sponsor
- NVT GmbH
Hepatic Tumor
Multicenter Study to Evaluate a New Robotic Device for Image-guided Percutaneous Needle Placement
This study evaluates the safety and performance of a new robotic device in the treatment of hepatic thermoablation in adults. The new robotic device will be used in all patients.
- Trial name
- NCT04230642
- Testing
- The Quantum Surgical device
- Where
- 2 sites in France
- Volunteers
- 22 people
- Sponsor
- Quantum Surgical
Surgical Site Infection
Betadine Versus Saline in Swapping of Subcutaneous Tissue
Caesarean section is an increasingly common major surgical procedure performed on women. Last decade an overall increase of the global rate of caesarean section, of up to 31.2%, was reported.
- Trial name
- NCT06595823
- Testing
- Betadine
- Where
- Egypt
- Volunteers
- 300 people
- Sponsor
- Egymedicalpedia
HCC
CT011 Autologous CAR-T Cells in Patients With Hepatocellular Carcinoma at Risk of Recurrence After Surgical Resection
A Single-arm, Open-label, Multicenter, Phase Ib Clinical Trial to Evaluate the Safety and Efficacy of CT011 Autologous CAR-T Cells in Patients with Hepatocellular Carcinoma at Risk of Recurrence after Surgical Resection.
- Trial name
- NCT06560827
- Testing
- CT011 CAR-GPC3 T Cells Injection
- Where
- 15 sites in China
- Volunteers
- 30 people
- Sponsor
- CARsgen Therapeutics Co., Ltd.
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
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