Clinical trials: Prolapse
Vaginal Vault Prolapse
Laparoscopic Versus Vaginal Approach Closure Complications
Hysterectomy is considered as a common operation in Gynecology. Hysterectomy could be made by vaginally, laparoscopically or abdominally.
- Trial name
- NCT05960292
- Testing
- Laparoscopic and Vaginal Hysterectomy
- Where
- Egypt
- Volunteers
- 56 people
- Sponsor
- Egymedicalpedia
Genital Prolapse
Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair
The purpose of this study is to prospectively follow patients after a sacrocolpopexy with Restorelle® mesh for apical prolapse repair as part of routine care.
- Trial name
- REPAIR (NCT06296316)
- Testing
- Restorelle Polypropylene Mesh
- Where
- 6 sites in France
- Volunteers
- 39 people
- Sponsor
- Coloplast A/S
Lumbar Disc Prolapse With Radiculopathy
Safety Study of ARO Spinal System as an Adjunct to Lumbar Decompression
To evaluate the clinical safety and effectiveness of the ARO Spinal System and to assess preliminary cost/benefit analysis in patients undergoing decompression surgery for symptomatic lumbar disc herniations.
- Trial name
- NCT01970514
- Testing
- ARO Spinal System
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- ARO Medical
Pelvic Organ Prolapse, Genital Prolapse
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
The purpose of the clinical investigation is to generate clinical data to substantiate the safety and performance of the i-Stitch device for bilateral sacrospinous ligament fixation (SSLF) in pelvic organ prolapse (POP) repair.
- Trial name
- i-StitchSSLF (NCT06805006)
- Testing
- SSLF
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Mitral Valve Regurgitation
Safety and Performance Study of the NeoChord Device
The purpose of this study is to demonstrate the safety and performance of the NeoChord DS1000 Artificial Chordae Delivery System in implanting ePTFE sutures(s) as artificial neochordae in patients with mitral regurgitation.
- Trial name
- TACT (NCT01777815)
- Testing
- NeoChord DS1000 Artificial Chordae Delivery System
- Where
- 8 sites in Denmark, Germany and 2 more
- Volunteers
- 30 people
- Sponsor
- NeoChord
Mitral Valve Repair, Mitral Regurgitation
ChordArt System for Mitral Regurgitation
The ChordArt System is a novel catheter based technology for mitral chordal replacement that enables controlled implantation of artificial mitral chords to treat mitral regurgitation with a minimally invasive approach.
- Conditions
- Mitral Valve Repair, Mitral Regurgitation, Mitral Valve Insufficiency
- Trial name
- CHAGALL (NCT03581656)
- Testing
- ChordArt System
- Where
- Lithuania
- Volunteers
- 5 people
- Sponsor
- CoreMedic GmbH
Pelvic Organ Prolapse
Restorelle® Mesh Versus Native Tissue Repair for Prolapse
The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle.
- Trial name
- NCT02162615
- Testing
- Restorelle Direct Fix A, Restorelle Direct Fix P, Native Tissue Repair Anterior
- Where
- 49 sites in United States, Australia and 4 more
- Volunteers
- 810 people
- Sponsor
- Coloplast A/S
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
Pelvic Organ Prolapse
Study of the Elevate Anterior and Apical 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® Anterior and Apical Prolapse Repair System for repair of anterior/apical pelvic organ prolapse in a controlled, post-market cohort study.
- Trial name
- Embrace (NCT02121977)
- Testing
- Elevate Anterior and Apical, Native Tissue Repair for pelvic organ prolapse
- Where
- 31 sites in United States
- Volunteers
- 285 people
- Sponsor
- ASTORA Women's Health
Pelvic Organ Prolapse
Xenform Postmarket Surveillance Study
To compare transvaginal repair with a biologic graft to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.
- Trial name
- Xenform (NCT01945580)
- Testing
- Prolapse Repair
- Where
- 25 sites in United States
- Volunteers
- 374 people
- Sponsor
- Boston Scientific Corporation
Mitral Valve Regurgitation, Mitral Valve Prolapse
CE Mark Study for the Harpoon Medical Device in Poland
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant advantages over current surgical interventions including: 1) a small minimally…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- NCT02432196
- Testing
- Harpoon Medical Device
- Where
- 2 sites in Poland
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Dermatochalasis of Upper Eyelid, Ptosis, Eyelid
Comparative Study of Ziplyft Treatment vs. Traditional Blepharoplasty for Upper Eyelid Rejuvenation
This study will compare two surgery techniques used for upper eyelid (eyelift) surgery: traditional surgery and a newer method called Ziplyft (a non-powered, hand-held clamp).
- Conditions
- Dermatochalasis of Upper Eyelid, Ptosis, Eyelid, Blepharoplasty
- Trial name
- NCT07250139
- Testing
- Ziplyft Device, Comparator Arm: Standard Blepharoplasty
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Osheru Inc.
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
Vaginal Delivery, Pelvic Organ Prolapse
Materna Prep Study Phase II
This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery.
- Trial name
- EASE (NCT06126328)
- Testing
- Materna Prep Device
- Where
- 15 sites in United States
- Volunteers
- 214 people
- Sponsor
- Materna Medical
Abnormal Uterine Bleeding, Endometriosis
Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy
The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic…
- Conditions
- Abnormal Uterine Bleeding, Endometriosis, Uterine Prolapse, Uterine Cancer
- Trial name
- BARHYSTER (NCT06024109)
- Testing
- Closure of the Vaginal Cuff after Total Hysterectomy
- Where
- 2 sites in Germany, Spain
- Volunteers
- 132 people
- Sponsor
- Aesculap AG
Pelvic Organ Prolapse
Prospective Long-term Evaluation of the Efficacy and Safety of Calistar S for Transvaginal Pelvic Organ Prolapse Repair
Prospective long-term evaluation of the performance and safety of Calistar S for transvaginal pelvic organ prolapse repair in women with anterior POP with or without apical vaginal involvement
- Trial name
- CASPO (NCT03821142)
- Testing
- Transvaginal mesh for anterior pelvic organ prolapse repair
- Where
- 6 sites in Germany
- Volunteers
- 180 people
- Sponsor
- Promedon
Thymoma, Mediastinal Tumor
Clinical Investigation of the da Vinci Surgical System
This prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da Vinci Surgical System in performing robotic-assisted surgical procedures.
- Conditions
- Thymoma, Mediastinal Tumor, Gynecologic Disease, Gynecologic Cancer
- Trial name
- NCT05682742
- Testing
- Robotic-assisted Surgery
- Where
- 4 sites in United States
- Volunteers
- 53 people
- Sponsor
- Intuitive Surgical
Vaginal Prolapse
Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse
Pelvic floor prolapse is a general term used to describe various clinical conditions that are associated with pelvic floor (muscles that support the vagina) relaxation in female patients.Pelvic floor prolapse is thought to result…
- Trial name
- NCT00196495
- Testing
- Polypropylene Mesh
- Volunteers
- 90 people
- Sponsor
- Ethicon, Inc.
Cystocele, Uterine Prolapse
Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh
The purpose of this study is to determine the influence of anterior pelvic prolapse reconstruction with a titanized polypropylene mesh on patients quality of life.
- Trial name
- NCT02690220
- Testing
- TiLOOP® PRO Plus A
- Where
- 5 sites in Germany
- Volunteers
- 54 people
- Sponsor
- pfm medical gmbh
Rectal Prolapse
Safety and Performance Evaluation of a Biological Matrix Used for Rectal Prolapse Repair by Ventral Rectopexy
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Rectopexy membrane used in rectal prolapse repair by ventral rectopexy and to identify emerging risks in…
- Trial name
- NCT04130555
- Testing
- CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)
- Where
- 3 sites in France
- Volunteers
- 55 people
- Sponsor
- Meccellis Biotech