Clinical trials: Procidentia
Pelvic Organ Prolapse
Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
This study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.
- Trial name
- NCT01541748
- Testing
- Axis
- Where
- 5 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Pelvic Organ Prolapse, Urogenital Prolapse
Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen
This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued postoperative vaginal estrogen cream compared…
- Conditions
- Pelvic Organ Prolapse, Urogenital Prolapse, Vaginal Vault Prolapse, Cystocele
- Trial name
- IMPROVE (NCT02431897)
- Testing
- Conjugated Estrogens Cream
- Where
- 3 sites in United States
- Volunteers
- 206 people
- Sponsor
- University of Texas Southwestern Medical Center
Cholecystitis, Endometriosis
Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery
This is a two period cross-over study randomizing patients undergoing laparoscopic surgery into 2 different groups: group 1 in which patients receive "deep neuromuscular blockade" in the beginning portion of their laparoscopic…
- Conditions
- Cholecystitis, Endometriosis, Bowel Obstruction, Fibroids
- Trial name
- NCT02812186
- Testing
- Deep to Moderate NMB, Moderate to Deep NMB, Rocuronium
- Where
- United States
- Volunteers
- 79 people
- Sponsor
- Stony Brook University
Pelvic Organ Prolapse
Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial
Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Prolapse may be corrected by surgery using either a vaginal or abdominal incision.
- Trial name
- OPUS (NCT00460434)
- Testing
- TVT
- Where
- 8 sites in United States
- Volunteers
- 337 people, healthy volunteers welcome
- Sponsor
- NICHD Pelvic Floor Disorders Network
Rectal Cancer, Colon Cancer
Perfusion Assessment in Laparoscopic Left Anterior Resection
The purpose of this study is to demonstrate that NIR fluorescence angiography using the PINPOINT Endoscopic Fluorescence Imaging System ("PINPOINT System" or "PINPOINT") can assess viability of colon tissue during laparoscopic…
- Conditions
- Rectal Cancer, Colon Cancer, Crohn's Disease, Polyp
- Trial name
- PILLAR II (NCT01560377)
- Testing
- PINPOINT Endoscopic Fluorescence Imaging System
- Where
- 11 sites in United States
- Volunteers
- 147 people
- Sponsor
- Novadaq Technologies ULC, now a part of Stryker
Nerve Block, Pain, Postoperative
Pudendal Nerve Block in Vaginal Surgery
The objective of this this randomized controlled study is to determine whether a pudendal nerve block at the time of vaginal surgery is associated with improved postoperative pain control and decrease opioid consumption compared…
- Conditions
- Nerve Block, Pain, Postoperative, Pelvic Floor Disorders, Pelvic Organ Prolapse
- Trial name
- NCT04198714
- Testing
- Pudendal block
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- MetroHealth Medical Center
Visceral Prolapse
Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
The study is a multi-center, randomized, surgical trial of women with symptomatic post-hysterectomy apical (cuff) prolapse desiring surgical treatment.
- Trial name
- ASPIRe (NCT02676973)
- Testing
- Open, Robotic, or Laparoscopic, Transvaginal Native Tissue Repair, Uphold™ LITE
- Where
- 10 sites in United States
- Volunteers
- 360 people
- Sponsor
- NICHD Pelvic Floor Disorders Network
Urinary Retention Postoperative
Effect of Phenazopyridine on Prolapse Surgery Voiding Trials
To determine if phenazopyridine reduces the rate of postoperative urinary retention after pelvic organ prolapse surgery.
- Trial name
- EPOV (NCT03065075)
- Testing
- Phenazopyridine
- Where
- United States
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- University of Massachusetts, Worcester
Brachial Ptosis
Evaluation of the Ulthera® System for Treatment of the Brachia
This study is an evaluation of the Ulthera® System used to treat the upper arms for improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm treatment.
- Trial name
- NCT01713933
- Testing
- Ulthera® System
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Ulthera, Inc
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
Pelvic Organ Prolapse (POP)
Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study
This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A\&P mesh after vaginal reconstruction surgery.
- Trial name
- (A&P) (NCT01378065)
- Testing
- Restorelle Direct Fix A&P
- Where
- 6 sites in United States
- Volunteers
- 31 people
- Sponsor
- Coloplast A/S
Prolapse
Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder
The purpose of this study is to determine whether vaginal repair or abdominal repair is the procedure of choice for the surgical management of a prolapsed bladder.
- Trial name
- NCT00271102
- Testing
- anterior vaginal repair (colporrhaphy), abdominal paravaginal defect repair
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Geisinger Clinic
Pelvic Organ Prolapse
The Extended Operations And Pelvic Muscle Training In The Management Of Apical Support Loss Study
Women will be invited to participate in E-OPTIMAL at their last clinical follow-up visit for OPTIMAL (at 24 months post surgery).
- Trial name
- E-OPTIMAL (NCT01166373)
- Testing
- Enrollment video, SSLF, ULS
- Where
- 7 sites in United States
- Volunteers
- 285 people
- Sponsor
- NICHD Pelvic Floor Disorders Network
Vaginal Vault Prolapse, Pelvic Organ Prolapse
Prediction of Postsurgical Symptomatic Outcomes With Preoperative Pessary Use
This is a single center, prospective trial of pessary use prior to reconstructive pelvic floor surgery for pelvic organ prolapse.
- Conditions
- Vaginal Vault Prolapse, Pelvic Organ Prolapse, Uterine Prolapse, Pelvic Floor Prolapse
- Trial name
- NCT02680145
- Testing
- Preoperative Pessary Use
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- Mayo Clinic
Pelvic Organ Prolapse
Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies
The purpose of this research is to determine if there is a difference in total costs of care and return to health in women who undergo a laparoscopic abdominal sacrocolpopexy (ASC) compared to those undergoing the same procedure…
- Trial name
- ACCESS (NCT01124916)
- Testing
- Robotic assisted laparoscopic abdominal sacrocolpopexy, Standard laparoscopic abdominal sacrocolpopexy
- Where
- 2 sites in United States
- Volunteers
- 84 people
- Sponsor
- Loyola University
Vaginal Apical Prolapse
Comparing Force of Stream to Retrograde Fill Voiding Trial After Vaginal Apex Suspension
Voiding difficulties are common after prolapse and incontinence surgeries. All patients after vaginal prolapse surgery must complete a voiding trial if they are to be discharged home without a catheter.
- Trial name
- NCT02753920
- Testing
- voiding trial, Foley catheter
- Where
- United States
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- Northwell Health
Pelvic Organ Prolapse
Sacro-Spinous Ligaments Anterior Apical Anchoring
Anterior-apical compartment mesh implants for pelvic floor reconstruction are anchored here to the Sacro-Spinous ligaments and evaluated being a feasible and effective method.
- Trial name
- NCT01842464
- Testing
- Anterior Sacro-Spinous
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Western Galilee Hospital-Nahariya
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Pivotal Study of a Percutaneous Mitral Valve Repair System
EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVERESTIIRCT (NCT00209274)
- Testing
- Percutaneous mitral valve repair using MitraClip implant, Mitral valve repair or replacement surgery
- Where
- United States
- Volunteers
- 279 people
- Sponsor
- Abbott Medical Devices
Pelvic Organ Prolapse
Uterosacral Ligament Suspension Clip
This study seeks to gain a more thorough understanding of the postoperative location of the sutures placed during uterosacral ligament suspension.
- Trial name
- USLS (NCT02700997)
- Testing
- Vascular Clip
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- TriHealth Inc.
Hemorrhoid
Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidopexy Procedure
Trial Objectives The primary objectives of this clinical trial are to estimate the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set: overall performance defined by the successful creation of a normal staple line safety as…
- Trial name
- NCT01169311
- Testing
- Hemorrhoidopexy
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Medtronic - MITG