Clinical trials: Surgical
Kyphosis, Spinal Fractures
Intra-operative Assessment of the Intellirod LOADPRO Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
The LOADPRO Study is an intra-operative, non-significant risk (NSR) case series feasibility assessment of the Intellirod LOADPRO™ System measuring spinal rod strain in long spinal kyphotic corrective constructs.
- Trial name
- LOADPRO (NCT02768675)
- Testing
- LOADPRO
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Intellirod Spine
Fallopian Tube Cancer, Ovarian Cancer
Monoclonal Antibody Therapy in Treating Patients With Residual Disease From Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Following Surgery and Chemotherapy
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
- Conditions
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
- Trial name
- NCT00003634
- Testing
- oregovomab
- Where
- 46 sites in United States, Canada
- Volunteers
- 400 people
- Sponsor
- AltaRex
Surgery
The TransEnterix European Patient Registry
An open label observational registry trial in which participating centers enroll subjects who had or will have a laparoscopically assisted surgery using the Senhance Surgical System.
- Trial name
- TRUST (NCT03385109)
- Testing
- Surgery
- Where
- Germany
- Volunteers
- 4,080 people
- Sponsor
- Asensus Surgical
Cataracts, Meibomian Gland Dysfunction (MGD)
A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
This is a post-market, prospective, randomized, multi-center, bilateral, open-label, cross-over, comparative clinical study. Study group will undergo preoperative LipiFlow treatment and Control group will not receive preoperative…
- Trial name
- NCT03708367
- Testing
- LipiFlow Thermal Pulsation System
- Where
- 5 sites in United States
- Volunteers
- 117 people
- Sponsor
- Johnson & Johnson Surgical Vision, Inc.
Obesity
LapBand Adjustment to Improve Early Weight Loss
Subjects having a gastric band fitted will have the first band adjustment done at surgery. The stoma will be set to 7mm using the EndoFLIP system to measure stoma size.
- Trial name
- NCT01060592
- Testing
- EndoFLIP device (FDA Device Listing Number : D091203)
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Crospon
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
General Anesthesia
Efficacy and Safety of HSK3486 Compared to Propofol for Adults Undergoing Elective Surgery With General Anesthesia
To demonstrate HSK3486 0.4/0.2 mg/kg (0.4 mg/kg intravenous [IV] slow injection over 30 [±5] seconds for the first dose, an additional 0.2 mg/kg if needed) is non-inferior to propofol 2.0/1.0 mg/kg (2.0 mg/kg IV slow injection…
- Trial name
- NCT05478174
- Testing
- HSK3486, Propofol
- Where
- 23 sites in United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Haisco-USA Pharmaceuticals, Inc.
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
Coronary Artery Disease
VENEK: Healing in Different Vein Harvesting Methods During Aortocoronary Coronary Artery Bypass Graft Surgery (CABG)
The VENEK trial is a randomized, prospective trial to compare economic parameters, quality of life and wound healing after endoscopic vein harvesting versus open vein harvesting.
- Trial name
- NCT00180388
- Testing
- endoscopic vein harvesting, open vein harvesting
- Where
- 2 sites in Germany
- Volunteers
- 300 people
- Sponsor
- Boston Scientific Corporation
Osteoarthritis, Pain Assessment
A Study to Evaluate the Effectiveness and Safety of Multiple Doses of Tapentadol(CG5503) in Patients Awaiting Joint Replacement Surgery
The purpose of this study is to evaluate in patients who are eligible for elective primary total or partial joint replacement of the hip or knee due to chronic osteoarthritis the efficacy (level of pain control) of CG5503 over 5…
- Conditions
- Osteoarthritis, Pain Assessment, Arthralgia
- Trial name
- NCT00361582
- Testing
- CG5503 IR; tapentadol
- Volunteers
- 669 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Postoperative Pain
Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery
Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving…
- Trial name
- NCT00266786
- Testing
- Intranasal Ketorolac Tromethamine
- Where
- 6 sites in United States, New Zealand
- Volunteers
- 321 people
- Sponsor
- Egalet Ltd
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.
Obstructive Sleep Apnea
Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com)
The purpose of this clinical trial is to demonstrate long-term safety and efficacy of the Inspire system. The Inspire Upper Airway Stimulation (UAS) therapy is intended to treat moderate-to-severe obstructive sleep apnea by…
- Trial name
- STAR (NCT01161420)
- Testing
- Inspire Upper Airway Stimulation System
- Where
- 22 sites in United States, Belgium and 3 more
- Volunteers
- 929 people
- Sponsor
- Inspire Medical Systems, Inc.
Recurrent Head and Neck Cancer
Study of RM-1929 and Photoimmunotherapy in Patients With Recurrent Head and Neck Cancer
This is a two-part clinical study of patients with recurrent Head and Neck Cancer (HNC), who in the opinion of their physician, cannot be satisfactorily treated with surgery, radiation or platinum chemotherapy.
- Trial name
- NCT02422979
- Testing
- PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 160 mg/m^2, PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 320 mg/m^2, PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 640 mg/m^2
- Where
- 7 sites in United States
- Volunteers
- 40 people
- Sponsor
- Rakuten Medical, Inc.
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