Clinical trials: Pelvic Surgery
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
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
Hemorrhage, Soft Tissue Bleeding
The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft tissue \& parenchymal bleeding during open…
- Conditions
- Hemorrhage, Soft Tissue Bleeding, Hepatic Parenchyma Bleeding
- Trial name
- NCT02227992
- Testing
- EVARREST™ Sealant Matrix, SURGICEL®
- Where
- 10 sites in Belgium, United Kingdom
- Volunteers
- 40 people
- Sponsor
- Ethicon, Inc.
Hemostasis, Surgical
The Safety and Effectiveness of PROCRIT (Epoetin Alfa) in Patients Undergoing Elective Major Abdominal and/or Pelvic Surgery
The primary purpose of the study is to compare the effect of perioperative (the time period describing the duration of a participants surgical procedure) administration of PROCRIT to that of Standard of Care (SOC) on the…
- Trial name
- NCT00350519
- Testing
- Epoetin alfa, Standard of Care
- Volunteers
- 37 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Pelvic Organ Prolapse
Feasibility Study of the Reia Vaginal Pessary
The purpose of this study is to obtain preliminary data on the effectiveness, safety, function, comfort, and patient satisfaction with a novel vaginal pessary design for the use in women who suffer from symptoms of pelvic organ…
- Trial name
- NCT04508335
- Testing
- Reia Vaginal Pessary
- Where
- 7 sites in United States
- Volunteers
- 78 people
- Sponsor
- Reia, LLC
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.
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.
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.
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
Prostate Cancer
A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology
This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic lymph node cancer.
- Trial name
- NCT01667536
- Testing
- Drug: 99mTc-MIP-1404
- Where
- 35 sites in United States, Belgium and 6 more
- Volunteers
- 105 people
- Sponsor
- Molecular Insight Pharmaceuticals, 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
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