Clinical trials: Apical Prolapse
Mitral Valve Regurgitation, Mitral Valve Prolapse
CE Mark Study for the Harpoon Medical Device
The purpose 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 including: 1) a…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- TRACER (NCT02768870)
- Testing
- Harpoon Artificial ePTFE Chords
- Where
- 4 sites in Italy, United Kingdom
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Pelvic Organ Prolapse
Uphold LITE Post-Market Surveillance Study
The purpose of this study is to compare transvaginal mesh repair to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.
- Trial name
- Uphold LITE (NCT01917968)
- Testing
- Uphold Lightweight Vaginal Support System, Traditional native tissue repair
- Where
- 28 sites in United States
- Volunteers
- 289 people
- Sponsor
- Boston Scientific Corporation
Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent
Multicenter, Prospective, Non-randomized, Single-arm, Interventional Study for the Evaluation of the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
A prospective, single arm, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients
- Trial name
- NCT03195361
- Testing
- SRS - Self Retaining Support system
- Where
- 3 sites in Israel
- Volunteers
- 50 people
- Sponsor
- Lyra Medical Ltd.
Pelvic Organ Prolapse
Comparison of Sacrospinous Ligament Fixation and Uterosacral Ligament Suspension for Apical Prolapse Surgery: A Randomized Clinical Trial
the main aim of this study is to study the anatomical and functional outcomes of two vaginal apical fixation procedures; sacrospinous ligament fixation and uterosacral ligament suspension, for pelvic organ prolapse surgery.
- Trial name
- NCT05668130
- Testing
- Sacrospinous ligament fixation, Uterosacral Ligament Suspension
- Volunteers
- 194 people
- Sponsor
- B.P. Koirala Institute of Health Sciences
Pelvic Organ Prolapse
Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Techniques in Uterine-preserving Apical Prolapsus Repair
The aim of the study will be to compare the laparoscopic pectopexy (LP) and laparoscopic lateral suspension (LLS) techniques in the management of uterine sparing apical prolapse (POP-Q >2) at 1 year and yearly up to 2 years.
- Trial name
- NCT05143658
- Testing
- LLS versus LP
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
Pelvic Organ Prolapse
Three-dimensional Ultrasound Assessment in Cases of Prolapse Surgeries
The levator ani muscle seems to play a key role in pelvic floor dysfunction. This muscle has two major components, the pubovisceral (including the pubococcygeus and puborectalis muscles) and the iliococcygeal muscles.Major…
- Trial name
- NCT03857724
- Testing
- prolapse surgery
- Where
- Egypt
- Volunteers
- 1 people
- Sponsor
- Assiut University
Pelvic Organ Prolapse Vaginal Surgery, Pelvic Organ Prolapse (POP)
Effectiveness of Perineorrhaphy in Pelvic Organ Prolapse Surgery
This is an observational registry-based study of long-term outcome after vaginal native tissue repair for pelvic organ prolapse designed to emulate a pragmatic open-label two-arm trial for which patients, in whom perineorrhaphy…
- Trial name
- PINPOPS (NCT07006129)
- Testing
- Perineorrhaphy, No perineorrhaphy
- Where
- Sweden
- Volunteers
- 40,646 people
- Sponsor
- Lund University
Pelvic Organ Prolapse
Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment
This is a prospective randomized controlled study, designed to compare efficacy and safety of two methods of apical fixation in patients with pelvic organ prolapse (POP) - sacrospinous hysteropexy (SSHP) with synthetic mesh and…
- Trial name
- NCT05420831
- Testing
- Vaginal, Laparoscopic
- Where
- Russia
- Volunteers
- 110 people
- Sponsor
- Saint Petersburg State University, Russia
Pelvic Organ Prolapse (POP), Urinary Incontinence , Stress
A Novel Laparoscopic Apical Promontofixation Technique With Simultaneous Perineal Reconstruction for Patients With Symptomatic Pelvic Organ Prolapse
Pelvic organ prolapse in women is a common gynecological condition worldwide, with prevalence reported by different authors ranging from 15% to 50%.
- Conditions
- Pelvic Organ Prolapse (POP), Urinary Incontinence , Stress, Urinary Incontinence (UI), Female Sexual Dysfunction (FSD)
- Trial name
- NCT07271862
- Testing
- Laparoscopic sacrocolpopexy., Laparoscopic apical promontofixation combined with simultaneous vaginal and perineal reconstruction using native tissues.
- Where
- Latvia
- Volunteers
- 60 people
- Sponsor
- Riga East Clinical University Hospital
Pelvic Organ Prolapse
Unilateral Versus Bilateral High Uterosacral Ligament Suspension Following vNOTES Hysterectomy for Apical Pelvic Organ Prolapse: A Prospective Study
This study aims to compare unilateral and bilateral high uterosacral ligament suspension techniques performed following vaginal hysterectomy in patients with pelvic organ prolapse.
- Trial name
- HUSLS (NCT07552337)
- Testing
- High Uterosacral Ligament Suspension
- Where
- Turkey (Türkiye)
- Volunteers
- 160 people
- Sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Pelvic Organ Prolapse
Comparison of Vaginal Axis on MRI in Alternative Apical Prolapse Surgeries to Sacrocolpopexy
Sacrocolpopexy remains the preeminent modality in addressing apical prolapse surgically. Nevertheless, amplified morbidity rates within cohorts characterized by obesity and advanced age constrain the advantages conferred by the…
- Trial name
- NCT06072456
- Testing
- laparoscopic lateral suspension, laparoscopic pectopexy, Sacrospinous ligament fixation
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
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
Study of the Elevate Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse
The aim of this study is to further evaluate the safety and efficacy of the Elevate® Apical and Posterior Prolapse Repair System for repair of apical/posterior pelvic organ prolapse in a controlled, post-market cohort study.
- Trial name
- Harmony 522 (NCT02123992)
- Testing
- Elevate Apical and Posterior, Native Tissue Repair for pelvic organ prolapse
- Where
- 23 sites in United States
- Volunteers
- 99 people
- Sponsor
- ASTORA Women's Health
Pelvic Organ Prolapse
the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse
The study is a prospective study at a single institution. Investigators create strict inclusion and exclusion criteria, selecting 124 patients with POP(≥II degree and have symptoms that need operation) .
- Trial name
- NCT05189665
- Testing
- Extraperitoneal high sacral ligament suspension surgery, Sacrospinous ligament fixation
- Where
- China
- Volunteers
- 124 people
- Sponsor
- Peking University People's Hospital
Pelvic Organ Prolapse
Apical Support During Hysterectomy for Pelvic Organ Prolapse
This is a retrospective chart review using TriHealth Electronic Privacy Identification Center (EPIC) to determine whether gynecologic surgeons at a large community hospital are already meeting the recently recommended best…
- Trial name
- NCT03379246
- Where
- United States
- Volunteers
- 236 people
- Sponsor
- TriHealth Inc.
Prolapse Genital, Prolapse Uterovaginal
Posterior Mesh Fixation at the Levator Ani Level in Apical Pelvic Organ Prolapse
This is a prospective, randomized, multicenter, non-inferiority trial including women with stage II-IV apical pelvic organ prolapse (POP), classified according to the POP-Q system.
- Conditions
- Prolapse Genital, Prolapse Uterovaginal, Prolapse; Female
- Trial name
- FIMEA (NCT07194343)
- Testing
- Laparoscopic colposacropexy with levator ani muscle mesh fixation, Simplified modification of laparoscopic colposacropexy
- Where
- 6 sites in Spain
- Volunteers
- 190 people
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Prolapse Genital
Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Treatment of Anterior and Apical Genitourinary Prolapse
The investigators anticipate a reduced risk of post-operational de novo stress urinary incontinence following surgery for vaginal sacrospinofixation, associated with reduced costs, comparable functional and anatomical efficacy…
- Trial name
- SAPPRO (NCT03200327)
- Testing
- promontofixation, sacrospinofixation
- Where
- 6 sites in France
- Volunteers
- 55 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Pelvic Organ Prolapse
Lateral Suspension Versus Sacral Colpopexy POP
The aim of the study will be to compare the SCP and LLS in the management of apical prolapse at 6 weeks, 6 months, 1 year and yearly up to 2 years with the null hypothesis being that no significant differences existed between the…
- Trial name
- LLS vs SCP (NCT03644628)
- Testing
- Laparoscopic repair of anterior and apical pelvic organ prolapse
- Volunteers
- 200 people
- Sponsor
- Medical University of Vienna
Pelvic Organ Prolapse, Surgery
Comparison of Two Apical Repair Methods in Women Undergoing Repairs for Prolapse
To date no study has determined prospectively which technique is superior to prevent recurrent Pelvic Organ Prolapse (POP) after vaginal hysterectomy- a major unmet clinical need.
- Conditions
- Pelvic Organ Prolapse, Surgery, Quality of Life, Complication
- Trial name
- NCT03113513
- Testing
- fixation of the vaginal apex
- Where
- Austria
- Volunteers
- 312 people, healthy volunteers welcome
- Sponsor
- Medical University of Graz
Pelvic Organ Prolapse
Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse
This prospective, multi center cohort trial aims to evaluate the efficacy and safety of hysteropexy using Splentis via the vaginal route in primary uterine prolapse
- Trial name
- SAXO (NCT05042453)
- Testing
- Splentis® POP Tissue Anchoring System
- Where
- 7 sites in Germany
- Volunteers
- 140 people
- Sponsor
- Promedon