Clinical trials: Surgical Injury
Ureter Injury
A Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic Colorectal Surgery
This study evaluates the safety and feasibility of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
- Trial name
- NCT05769257
- Testing
- IS-001
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Intuitive Surgical
Carpal Tunnel Syndrome (CTS)
Effectiveness of Amniotic Membrane Combined With Secretome as an Adjunct to Carpal Tunnel Release Surgery: Evaluation Using the Boston Carpal Tunnel Questionnaire and Electromyography
Carpal Tunnel Syndrome (CTS) is a compressive neuropathy caused by chronic compression of the median nerve within the carpal tunnel, resulting in pain, numbness, tingling, and impaired hand function.
- Trial name
- Secretome CTS (NCT07723313)
- Testing
- Secretome, amniotic membrane, Standard surgery
- Where
- Indonesia
- Volunteers
- 30 people
- Sponsor
- PT. Prodia Stem Cell Indonesia
Pain, Postoperative
Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery
The purpose of this research study is to evaluate the safety and analgesic efficacy of PMI-150 (intranasal ketamine) compared to placebo in patients with acute post-operative pain following orthopedic trauma, injury, or surgery.
- Trial name
- NCT00709436
- Testing
- PMI-150 (intranasal ketamine)
- Where
- 16 sites in United States
- Volunteers
- 250 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Breast Surgery, Regeneration
Clinical Investigation of an Ozonated Oil for the Regeneration and Healing of Surgical Wounds in Patients Undergoing Breast Surgery
This is a multicentre, prospective, randomised, double-blind, placebo-controlled clinical study designed to evaluate the regenerative and wound-healing efficacy of OZOAQUA MD OZONATED OIL in surgical wounds in patients undergoing…
- Conditions
- Breast Surgery, Regeneration, Surgical Wound Healing
- Trial name
- NCT07809308
- Testing
- ozonated oil, Non ozonated oil
- Where
- 2 sites in Spain
- Volunteers
- 50 people
- Sponsor
- Laboratorios Ozoaqua
Wound Debridement
Chitosan Dressings to Facilitate Safe Effective Debridement of Chronic Wounds & Minimize Wound Bacterial Re-colonization
The purpose of this study is to determine if the use of HemCon chitosan-based dressings is effective to facilitate safe, effective debridement of chronic wounds in the operating room and inpatient ward settings and to minimize…
- Trial name
- NCT01035944
- Testing
- HemCon Dressings and HemCon ChitoGauze; chitosan-based., Gauze and saline dressings.
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- HemCon Medical Technologies, Inc
Elastosis
PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty
The objective of this clinical study is to evaluate healing of incisions made with the PEAK PlasmaBlade 4.0 compared to scalpel and traditional electrosurgery (Bovie); to monitor and record key post-operative metrics following…
- Trial name
- PRECISE (NCT00943150)
- Testing
- PEAK PlasmaBlade, Standard of Care (SOC)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medtronic Surgical Technologies
Wound of Skin, Abdominal Wound
Safety and Efficacy of MRG-001 in Wound Healing in Abdominoplasty Patients
Surgical excisions are one of the most frequent cutaneous wounds. This study will compare the safety and preliminary efficacy of a novel fixed-dose combination drug MRG-001 in pre-abdominoplasty surgical excisions and scar…
- Trial name
- NCT05844527
- Testing
- MRG-001, Saline
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- MedRegen LLC
Orthognathic Surgery, Maxillofacial Abnormalities
Study Evaluating the Performance and Safety of Global D Implants Indicated for Orthognathic Surgery
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK®) used for…
- Conditions
- Orthognathic Surgery, Maxillofacial Abnormalities, Maxilla Fracture
- Trial name
- CMF-ORTHO (NCT05271383)
- Testing
- Orthognathic surgery using Global D's implants.
- Where
- France
- Volunteers
- 198 people
- Sponsor
- Global D
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.
Hernia, Ventral, Hernia, Hiatal
GORE® ENFORM Biomaterial Product Study
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair).
- Conditions
- Hernia, Ventral, Hernia, Hiatal, Hernia, Diaphragmatic, Incisional Hernia
- Trial name
- ENF 18-06 (NCT04718168)
- Testing
- Gore ENFORM Biomaterial (Preperitoneal), Gore ENFORM Biomaterial (Intraperitoneal)
- Where
- 9 sites in United States
- Volunteers
- 245 people
- Sponsor
- W.L.Gore & Associates
Kidney Injury Following Open-Chest Cardiac Surgery
A Phase 2b Dose Finding Study of RMC-035 in Participants Undergoing Open-chest Cardiac Surgery
The goal of this clinical trial is to identify the optimal dose of RMC-035 for protection of long-term renal function in adult patients undergoing cardiac surgery who are at high risk of kidney injury.
- Trial name
- POINTER (NCT06475274)
- Testing
- RMC-035
- Where
- 19 sites in Canada, Czechia and 2 more
- Volunteers
- 170 people
- Sponsor
- Guard Therapeutics AB
Degenerative Disc Disease (DDD), Spinal Stenosis
PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials
This is a prospective, multi-center, observational Post-Market Clinical Follow-Up (PMCF) study designed to collect additional safety and clinical performance data on CE-marked Titania® spinal instrumentation and fusion systems…
- Conditions
- Degenerative Disc Disease (DDD), Spinal Stenosis, Spondylolisthesis, Spinal Deformities
- Trial name
- INFO SPINE (NCT07615491)
- Testing
- Titania® Cervical Interbody Fusion Cage (Titanium), Titania® Cervical Interbody Fusion Cage (PEEK), Titania® Posterior Cervical Stabilization System
- Where
- 3 sites in Turkey (Türkiye)
- Volunteers
- 561 people
- Sponsor
- Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.
Bladder Cancer, Prostate Cancer
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
This study will evaluate the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.
- Conditions
- Bladder Cancer, Prostate Cancer, Kidney Cancer, Pelvic Tumor
- Trial name
- NCT05696444
- Testing
- RAS Prostatectomy, RAS Cystectomy, RAS Nephrectomy
- Where
- 6 sites in United States
- Volunteers
- 144 people
- Sponsor
- Medtronic - MITG
Cartilage Injury of Knee
A Multicenter Trial of Sprifermin (AS902330 [Recombinant Human Fibroblast Growth Factor-18]) or Placebo After Microfracture Surgery for Cartilage Injury of the Knee
This is a Phase 2, double-blind, multicenter, randomized, placebo-controlled trial to evaluate the efficacy and safety of Sprifermin (AS902330) (recombinant human fibroblast growth factor-18 [rhFGF-18]) as an adjunct treatment to…
- Trial name
- NCT01689337
- Testing
- Sprifermin (AS902330)
- Volunteers
- 1 people
- Sponsor
- EMD Serono
Laceration
A Randomized Post-market Study to Evaluate Zip Device Compared to Sutures for Laceration Repair in Pediatrics and Adults
The Zip-009 clinical investigation will enroll 26 paediatric and adult subjects requiring laceration repair and fulfilling the eligibility criteria for the clinical investigation.
- Trial name
- NCT03199456
- Testing
- Zip surgical skin closure device, Standard of Care sutures
- Where
- 2 sites in Sweden
- Volunteers
- 26 people
- Sponsor
- ZipLine Medical Inc.
Surgical Site Infection
Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections
The purpose of this study is to assess the efficacy and safety of delafloxacin administered as IV and oral formulation in comparison with Best Available Therapy (BAT) in patients with superficial or deep incisional surgical site…
- Trial name
- DRESS (NCT04042077)
- Testing
- Delafloxacin, Vancomycin, Linezolid
- Where
- Italy
- Volunteers
- 268 people
- Sponsor
- Menarini Group
Ureter Injury
A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation.
- Trial name
- NCT03937505
- Testing
- IS-001, No treatment
- Where
- 3 sites in United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Intuitive Surgical
Systemic Inflammation, Cardiopulmonary-bypass
Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase
Study should demonstrate that alkaline phosphatase reduces the incidence and extent of acute kidney injury after cardiopulmonary bypass (CPB) as defined by the AKIN criteria.
- Trial name
- APPIRED-III (NCT03050476)
- Testing
- RESCAP®
- Where
- 21 sites in Australia, Austria and 9 more
- Volunteers
- 1,250 people
- Sponsor
- Alloksys Life Sciences B.V.
Atrial Fibrillation, AFib
Stroke Feasibility Study
This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage.
- Trial name
- NCT01997905
- Testing
- AtriClip LAA Exclusion Device
- Where
- 7 sites in United States
- Volunteers
- 13 people
- Sponsor
- AtriCure, Inc.
Surgical Site Infection
Air Barrier System for the Prevention of Surgical Site Infection
Airborne particles are present in all indoor environments including the operating room. Most of these particles come from the surgical staff moving around in the room, positioning of the patient during surgery, and the movement…
- Trial name
- ABS (NCT01610271)
- Testing
- Air Barrier System
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Nimbic Systems, LLC