Clinical trials: Pelvic Surgery
Cancer, Venous Thromboembolism
CANBESURE STUDY (Cancer, Bemiparin and Surgery Evaluation)
The aim of the study is to evaluate the efficacy and safety of Bemiparin, a second-generation LMWH, in the prophylaxis of VTE (using a postoperative regimen, i.e.
- Trial name
- NCT00219973
- Testing
- Bemiparin
- Where
- 4 sites in Portugal, Romania and 2 more
- Volunteers
- 526 people
- Sponsor
- Rovi Pharmaceuticals Laboratories
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.
Pelvic Organ Prolapse
Post-market Clinical Follow-up of the SRS Implant
National, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant
- Trial name
- NCT05170074
- Where
- 6 sites in Germany
- Volunteers
- 97 people
- Sponsor
- pfm medical gmbh
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
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
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
Pelvic Organ Prolapse (POP), Synthetic Mesh
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
The purpose of this clinical investigation is to collect clinical data about the ProGYNious Mesh based on a prospective clinical investigation.
- Conditions
- Pelvic Organ Prolapse (POP), Synthetic Mesh, Laparoscopic Surgery, Gynecologic Laparoscopic Surgery
- Trial name
- ProGYNious (NCT07497321)
- Testing
- Surgical mesh for pelvic organ prolapse repair (ProGYNious)
- Where
- 5 sites in Austria, Germany
- Volunteers
- 100 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Soft Tissue Bleeding
The Severe Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling challenging severe soft tissue bleeding during abdominal, pelvic…
- Trial name
- NCT00977925
- Testing
- Fibrin Pad, Standard of Care
- Where
- 17 sites in Australia, Germany and 2 more
- Volunteers
- 91 people
- Sponsor
- Ethicon, Inc.
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.
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 (POP), Genital Prolapse
Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)
The purpose of the clinical investigation is to verify that the investigational device (LatGYNious) is appropriate to significantly improve the pelvic organ prolapse in patients.
- Conditions
- Pelvic Organ Prolapse (POP), Genital Prolapse, Uterus Prolapse, Laparoscopic Surgery
- Trial name
- NCT07066761
- Testing
- Laparoscopic lateral suspension with surgical mesh (LatGYNious)
- Where
- 5 sites in Austria, Germany
- Volunteers
- 85 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
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.
Pelvic Organ Prolapse, Prolapse
Early Feasibility Study of the Reia Vaginal Pessary
This is an early feasibility open-label non-randomized trial to obtain preliminary information about the function and effectiveness of a novel vaginal pessary for the use in women who suffer from symptoms of pelvic organ prolapse…
- Trial name
- NCT04275089
- Testing
- Reia Vaginal Pessary
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Reia, LLC
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
Acquired Bleeding Disorder, Trauma
Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy of activated recombinant human factor VIIgiven in conjunction with standard therapy in patients undergoing major orthopaedic surgery following…
- Trial name
- NCT01601457
- Testing
- activated recombinant human factor VII
- Where
- United Kingdom
- Volunteers
- 48 people
- Sponsor
- Novo Nordisk A/S
Pain, Postoperative
A Comparison of the Safety and Effectiveness of Two Forms of Patient-controlled Pain Medication Used After Scheduled Abdominal or Pelvic Surgery: The Fentanyl Transdermal System Versus the Morphine Intravenous Pump
The purpose of this study is to compare two pain medications delivered by two different forms of patient-controlled pain management systems: the Fentanyl HCl Patient-Controlled Transdermal System (E-TRANS fentanyl) and the…
- Trial name
- NCT00266539
- Testing
- E-TRANS Fentanyl hydrochloride; Morphine
- Volunteers
- 506 people
- Sponsor
- Alza Corporation, DE, USA
Fracture;Pelvis, Sacral Fracture
Sacral Fracture Fusion/Fixation for Rapid Rehabilitation
To determine the safety and efficacy of concomitant sacral fracture fixation and sacroiliac (SI) joint fusion vs. non-surgical management for patients with debilitating sacral fragility or insufficiency fractures
- Conditions
- Fracture;Pelvis, Sacral Fracture, Sacroiliac; Fusion, Fragility Fracture
- Trial name
- SAFFRON (NCT05426356)
- Testing
- Surgical Intervention, Non-Surgical Management
- Where
- 7 sites in United States
- Volunteers
- 28 people
- Sponsor
- SI-BONE, Inc.
Pain, Postoperative
Efficacy and Safety of IV Diclofenac (DIC075V) for Pain After Abdominal or Pelvic Surgery
This study will compare repeated intermittent IV dosing of diclofenac in patients with moderate to severe post-surgical pain from abdominal or pelvic surgery.
- Trial name
- NCT00448110
- Testing
- Intravenous Diclofenac (DIC075V), Intravenous Ketorolac
- Where
- 14 sites in United States
- Volunteers
- 331 people
- Sponsor
- Javelin Pharmaceuticals
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
Lower Abdominal Surgery, Pelvic Surgery
Objective to Evaluate the Safety and Effectiveness of LED Light Source System for Endoscopy in Ureteral Radiography
This clinical trial is a prospective, multi-center, single-blind, parallel, randomized controlled superiority clinical trial. The trial will be carried out in 5 centers, involving 120 subjects as estimated who will be divided…
- Trial name
- IRIS (NCT04561414)
- Testing
- LED light source system for endoscope, Ureteral stent (Cook Ireland Ltd.)
- Where
- 4 sites in China
- Sponsor
- Stryker Orthopaedics