Clinical trials: Pelvic Surgery
Abdomino-pelvic Surgery, Bleeding
A Safety and Performance Study of the Use of EmboBio for the Intra-arterial Treatment of Abdominopelvic Bleeding
This research conducted by EMBOBIO SAS is intended for patients with bleeding or at risk of bleeding in the abdominal-pelvic region requiring embolization.
- Conditions
- Abdomino-pelvic Surgery, Bleeding, Embolization
- Trial name
- EMBOBIO-1 (NCT07199348)
- Testing
- Embobio
- Where
- France
- Volunteers
- 45 people
- Sponsor
- Embobio Medical
Hemostasis, Hemostatic Techniques
A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery
The objective of this clinical investigation is to evaluate the safety and efficacy of ETHIZIA to control minimal, mild, or moderate soft tissue bleeding during open surgery when compared to SURGICEL Original in the percentage of…
- Trial name
- NCT06664788
- Testing
- ETHIZIA, SURGICEL Original
- Where
- 7 sites in United States, Netherlands
- Volunteers
- 108 people
- Sponsor
- Ethicon, Inc.
Hemostasis
The Fibrin Patch Soft Tissue Study
The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding in abdominal, pelvic…
- Trial name
- NCT00658723
- Testing
- Fibrin Pad, SURGICEL™
- Where
- 11 sites in United States
- Volunteers
- 141 people
- Sponsor
- Ethicon, Inc.
Pelvic Organ Prolapse
A Surgical Simulation Study to Evaluate the Safety of a Device Mechanism as Treatment for Vaginal Apical Prolapse
The purpose of this pilot study is to perform a procedure to evaluate the safety of the placement of a new device (known as the VFIX device).
- Trial name
- NCT00965952
- Where
- 4 sites in Australia
- Volunteers
- 49 people
- Sponsor
- Ethicon, Inc.
Blood Loss
Clinical Evaluation of the CM-1500 in Postoperative Surgery Patients
The primary objective is to evaluate the the changes in the Relative Index in post abdominal or pelvic surgery patients on the Cardiac Monitor Model CM-1500.
- Trial name
- NCT04706221
- Testing
- CM-1500
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Zynex Monitoring Solutions
Cystocele, Uterine Prolapse
Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6
The purpose of this study is to determine the influence of Anterior Pelvic Prolapse Reconstruction with a titanised polypropylene mesh on rate of erosion and patients quality of live.
- Trial name
- NCT01084889
- Testing
- surgical mesh implantation (TiLOOP® Total 6)
- Where
- 9 sites in Germany
- Volunteers
- 292 people
- Sponsor
- pfm medical gmbh
Controlling Mild to Moderate Bleeding During Surgery
The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic…
- Trial name
- NCT03255174
- Testing
- EVARREST® Fibrin Sealant Patch
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Ethicon, Inc.
Non-Cardiac/ Non-Thoracic Surgery, Abdominal Surgery
Assisted Fluid Management IDE Study
The primary objective of this study is to evaluate the performance of the Acumen™ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness.
- Conditions
- Non-Cardiac/ Non-Thoracic Surgery, Abdominal Surgery, Pelvic Surgery, Major Peripheral Vascular Surgery
- Trial name
- AFM (NCT03469570)
- Testing
- EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature
- Where
- 10 sites in United States
- Volunteers
- 330 people
- Sponsor
- Edwards Lifesciences
Hemorrhage, Soft Tissue Bleeding
EVARREST™ Fibrin Sealant Patch Post-Market Study
The objective of this study is to evaluate the clinical utility of EVARREST™ Fibrin Sealant Patch (Fibrin Pad) as an adjunct to hemostasis in soft tissue bleeding during intra-abdominal (stomach area), retroperitoneal (hip and…
- Trial name
- EVARREST (NCT01902459)
- Testing
- EVARREST™ Fibrin Sealant Patch, Standard of Care
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Ethicon, Inc.
Postsurgical Pain
Efficacy and Safety Study of Ketorolac / Pitofenone / Fenpiverinium for the Treatment of Patients With Pain After Surgical Abdominal and Pelvic Operations
Neospastil (ketorolac tromethamine / pitofenone hydrochloride / fenpiverinium bromide fixed-dose combination) in a form of solution for injections and film-coated tablets has been studied as a treatment for pain after surgical…
- Trial name
- NCT05607641
- Testing
- Ketorolac tromethamine, solution for injection then Neospastil, film-coated tablets, Ketorolac tromethamine, solution for injection then Ketorolac tromethamine, coated tablets, Neospastil, solution for injection then Neospastil, film-coated tablets
- Where
- 14 sites in Ukraine
- Volunteers
- 424 people
- Sponsor
- Darnitsa Pharmaceutical Company
Pelvic Organ Prolapse
ACell MatriStem Pelvic Floor Matrix Versus Native Tissue Repair, Comparative Study
The primary objective of this study is to assess the safety and effectiveness of MatriStem Pelvic Floor Matrix as compared to native tissue repair for the treatment of pelvic organ prolapse.
- Trial name
- NCT02021279
- Testing
- MatriStem Pelvic Floor Matrix, native tissue repair
- Where
- 13 sites in United States
- Volunteers
- 161 people
- Sponsor
- Integra LifeSciences Corporation
Hemorrhage, Soft Tissue Bleeding
The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study
To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to achieve haemostasis during surgery in paediatric patients.
- Trial name
- NCT02227706
- Testing
- EVICEL® Fibrin Sealant, SURGICEL® Absorbable Hemostat
- Where
- 13 sites in Belgium, Canada and 1 more
- Volunteers
- 40 people
- Sponsor
- Ethicon, Inc.
Intra-operative Bleeding
Oxidized Cellulose hEmostAsis evaluatioN
The purpose of this study is to evaluate the safety and effectiveness of Traumastem to help stop bleeding in participants undergoing open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery as compared to…
- Trial name
- OCEAN (NCT01637025)
- Testing
- Oxidized cellulose strip, Oxidized regenerated cellulose strip
- Where
- 24 sites in Czechia, Germany and 2 more
- Volunteers
- 111 people
- Sponsor
- Baxter Healthcare Corporation
Prolapse, Sacrocolpopexy
Retrospective Data Analysis PelviGYNious/EndoGYNious
The retrospective patient chart review aims to generate additional data to substantiate the safety and performance of EndoGYNious and PelviGYNious.
- Conditions
- Prolapse, Sacrocolpopexy, Pelvic Organ Prolapse (POP)
- Trial name
- NCT06927752
- Testing
- PelviGYNious, EndoGYNious
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Uterine Fibroids (UF), Menstrual Disorders
Hugo™ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)
The purpose of this research is to evaluate the safety and performance of the investigational Medtronic Hugo™ Robotic Assisted Surgery (RAS) system when used during hysterectomy procedures, including patients being treated for…
- Conditions
- Uterine Fibroids (UF), Menstrual Disorders, Adenomyosis of Uterus, Endometriosis
- Trial name
- Embrace Gyn (NCT07120945)
- Testing
- Robotic Assisted-Surgery (RAS) Hysterectomy
- Where
- 5 sites in United States
- Volunteers
- 70 people
- Sponsor
- Medtronic - MITG
Female Stress Incontinence, Pelvic Organ Prolapse
Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices
To monitor post-market performance through evaluation of short and long-term performance via: Efficacy Safety Patient reported outcomes
- Trial name
- CAPTURE (NCT01673360)
- Testing
- Elevate PC, Mini Arc Pro, RetroArc
- Where
- 19 sites in United States, Canada and 6 more
- Volunteers
- 401 people
- Sponsor
- ASTORA Women's Health
Cystocele, Uterine Prolapse
Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh
The purpose of this study is to determine the influence of anterior pelvic prolapse reconstruction with a titanized polypropylene mesh on patients quality of life.
- Trial name
- NCT02690220
- Testing
- TiLOOP® PRO Plus A
- Where
- 5 sites in Germany
- Volunteers
- 54 people
- Sponsor
- pfm medical gmbh
Vaginal Prolapse
Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products
This registry was observational (only collected information typically noted by the surgeon when their patients were routinely seen); there was no change to the care the patient received as a result of being part of the registry).
- Trial name
- POWER1012 (NCT00388947)
- Testing
- AMS Prolapse Product
- Where
- United States
- Volunteers
- 1,543 people
- Sponsor
- ASTORA Women's Health
Gastrointestinal Dysfunction, Malnutrition
Postoperative GI Dysfunction and Nutrition in Malnourished Cancer Surgery Patients
This is a prospective two-center observational cohort study in adult patients undergoing major abdominal and/or pelvic oncologic surgery with pre-existing malnutrition.
- Conditions
- Gastrointestinal Dysfunction, Malnutrition, Delirium - Postoperative, Abdominal Neoplasm
- Trial name
- GIDNUT (NCT07622888)
- Testing
- Serotonin (e.g., serotonin adipinate), Standard Prokinetic Therapy (excluding serotonin)
- Where
- Russia
- Volunteers
- 120 people
- Sponsor
- Arma Ltd.
Vaginal Wall Prolapse
Surgical Repair of Vaginal Wall Prolapse Using Gamma Irradiated Amniotic Membrane as a Scaffold
The surgical repair of vaginal wall prolapse continues to remain one of the most difficult challenges in female pelvic floor reconstruction. The recurrence rate after standard colporrhaphy ranges from 40-60 %.
- Trial name
- NCT05355623
- Testing
- Vaginal Repair
- Where
- Egypt
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Egymedicalpedia