Clinical trials: Prolapse
Mitral Valve Regurgitation, Mitral Valve Prolapse
Safety and Performance Study of the Harpoon Mitral Valve Repair System
The primary objective of this study is to evaluate the safety and performance of the Harpoon Medical Device. It is anticipated, that the Harpoon Medical Device will provide advantages over current surgical interventions…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- NCT03285724
- Testing
- Harpoon Artificial ePTFE Chords
- Where
- 2 sites in Poland
- Volunteers
- 1 people
- Sponsor
- Edwards Lifesciences
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
FINPOP 2015: Incidence, Methods, Complications and Quality of Life of Pelvic Organ Prolapse Operations in Finland 2015
The aim of this study is to investigate the safety and effectivity of pelvic organ prolapse (POP) surgery. In this multi center study the population consists of POP operations done in Finland year 2015.The study is prospective…
- Trial name
- NCT02716506
- Testing
- POP surgery
- Where
- Finland
- Volunteers
- 3,515 people, healthy volunteers welcome
- Sponsor
- Society for Gynecological Surgery in Finland
Pelvic Organ Prolapse
Nitrofurantoin Prophylaxis During Catheter-managed Acute Urinary Retention After Pelvic Reconstructive Surgery
The specific aim of this randomized double-blind placebo-controlled trial is to determine if extended release nitrofurantoin antibiotic prophylaxis decreases the incidence of symptomatic urinary tract infection (UTI) compared…
- Trial name
- NCT02727322
- Testing
- Nitrofurantoin
- Where
- 2 sites in United States
- Volunteers
- 154 people
- Sponsor
- Halina M Zyczynski, MD
Obstetric; Injury Pelvic Floor
The Effect of Pregnancy and Labour on the Pelvic Floor Diagnosed With 3D and 4D Ultrasound
Injuries to the pelvic floor muscles and fascias during delivery and childbirth may lead to urinary incontinence (25-45 %), faecal incontinence (11-45%), pelvic organ prolapse (7-23%), sexual dysfunction (15-33 %) and chronic…
- Trial name
- NCT01045135
- Where
- Norway
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University Hospital, Akershus
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
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Real World Expanded Multicenter Study of the MitraClip® System (REALISM)
Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- REALISM (NCT01931956)
- Testing
- MitraClip® implant
- Where
- 38 sites in United States
- Volunteers
- 965 people
- Sponsor
- Abbott Medical Devices
Pelvic Organ Prolapse
IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair
The purpose of this study is to determine whether preoperative IV Acetaminophen reduces postoperative pain and narcotic consumption in women undergoing surgical repair of pelvic organ prolapse.
- Trial name
- NCT02155738
- Testing
- IV Acetaminophen, IV normal saline
- Where
- United States
- Volunteers
- 204 people
- Sponsor
- Halina M Zyczynski, MD
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.
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
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Feasibility Study of a Percutaneous Mitral Valve Repair System.
Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVEREST(I) (NCT00209339)
- Testing
- Percutaneous mitral valve repair (MitraClip Implant)
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Insufficiency, Mitral Valve Regurgitation
EVEREST II Pivotal Study High Risk Registry (HRR)
Prospective, multi-center, single arm registry. Clinical follow-up at discharge, 30 days, 6, 12, 18 and 24, months, and 3, 4 and 5 years.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- HRR (NCT01940120)
- Testing
- Percutaneous mitral valve repair using MitraClip implant
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Abbott Medical Devices
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
Anxiety
Patient Satisfaction Study: Clean Intermittent Self-Catheterization Teaching
To compare patient satisfaction and anxiety scores between female subjects undergoing urinary incontinence and/or pelvic reconstructive surgery who are instructed preoperatively in the technique of clean intermittent…
- Trial name
- NCT00678444
- Testing
- Educational video
- Where
- United States
- Volunteers
- 199 people
- Sponsor
- University of Pittsburgh
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
Genital Diseases, Female, Pelvic Organ Prolapse
A Long Term Follow up of Anterior Meshes for Recurrent Prolapse
Prolapse of the vaginal wall and uterus are common conditions affecting up to 50% of parous women. The socioeconomic, psychological and physical impacts of prolapse are considerable.
- Trial name
- NCT02642835
- Testing
- vaginal wall mesh
- Where
- United Kingdom
- Volunteers
- 48 people
- Sponsor
- Medway NHS Foundation Trust
Mitral Valve Insufficiency, Heart Valve Diseases
NeoChord TACT Post-Market Surveillance Registry
To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System
- Conditions
- Mitral Valve Insufficiency, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT01784055
- Where
- 7 sites in France, Germany and 3 more
- Volunteers
- 126 people
- Sponsor
- NeoChord
Pelvic Organ Prolapse
Improvement of Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse
To determine if the injection of liposomal bupivacaine to laparoscopic port sites and rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant rectocele repair will result in decreased…
- Trial name
- NCT02449915
- Testing
- Bupivacaine
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- TriHealth Inc.
Pelvic Organ Prolapse
Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse.
Pelvic organ prolapse is a common problem. A lot of women have surgery for prolapse. The recurrence rate op pelvic organ prolapse after surgical treatment is high.
- Trial name
- NCT00372190
- Testing
- Tensionfree vaginal mesh kit (Prolift), classic vaginal prolapse surgery (fascia plication)
- Where
- 13 sites in Netherlands
- Volunteers
- 194 people
- Sponsor
- Radboud University Medical Center
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