Clinical trials: Ptosis
Pelvic Organ Prolapse, Uterine Prolapse
Efficacy Study of Vaginal Mesh for Prolapse
The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome…
- Conditions
- Pelvic Organ Prolapse, Uterine Prolapse, Vaginal Prolapse, Cystocele
- Trial name
- VAMP (NCT00475540)
- Testing
- synthetic monofilament polypropylene mesh
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Medstar Health Research Institute
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
Vaginal Prolapse, Uterine Prolapse
Efficacy Study of Vaginal Mesh for Anterior Prolapse
The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome…
- Conditions
- Vaginal Prolapse, Uterine Prolapse, Cystocele, Pelvic Organ Prolapse
- Trial name
- VAMP-A (NCT00557882)
- Testing
- synthetic polypropylene mesh
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Medstar Health Research Institute
Pelvic Organ Prolapse
Smartmesh Technology in Pelvic Floor Repair Procedures
Pelvic organ prolapse repair involves conservative treatments and surgical treatments. Conservative treatments are for patients with moderate prolapse. Treatment of symptomatic prolapse remains essentially surgical.
- Trial name
- Restorelle (NCT03098641)
- Testing
- pelvic organ prolapse repair
- Where
- 16 sites in France
- Volunteers
- 272 people
- Sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
Prolapse
Randomized Trial of Y Mesh vs Dual Mesh
The primary objective of the proposed study is to determine the difference in suturing time when using the restorelle Y mesh versus the restorelle dual flat mesh at the time of laparoscopic and robotic-assisted laparoscopic…
- Trial name
- NCT02156687
- Testing
- Y mesh, Dual flat mesh
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- The Cleveland Clinic
Brow Ptosis
Photographic Assessment of Eyebrow Position and Range of Motion
Forehead and eyebrow surgery is a frequently performed cosmetic surgical procedure in which the eyebrows are raised to a more aesthetically pleasing position.
- Trial name
- NCT00347308
- Testing
- Eyebrow Position
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- The New York Eye & Ear Infirmary
Lower Eyelid Steatoblepharon (Excess Eyelid Fat)
Phase 2 Study of XAF5 (XOPH5) Ointment for Reduction of Excess Eyelid Fat (Steatoblepharon)
This study will test whether XAF5 (XOPH5) ointment, applied once daily to the lower eyelids for 10 weeks, reduces the prominence of lower eyelid fat in adults with moderate to severe steatoblepharon (excess eyelid fat).
- Trial name
- NCT02230761
- Testing
- XOPH5 Ointment
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Topokine Therapeutics, Inc.
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
Urethra Issue, Pelvic Organ Prolapse
Lessons on Urethral Lidocaine in Urodynamics
This trial will assess whether use of intraurethral 2% lidocaine jelly meaningfully impacts sensation during filling (i.e., a change of more than 25% of first sensation, first desire to void, strong desire to void, or maximum…
- Conditions
- Urethra Issue, Pelvic Organ Prolapse, Urinary Incontinence, Vaginal Vault Prolapse
- Trial name
- LULU (NCT04038099)
- Testing
- Water-Based Vaginal Lubricant, lidocaine topical
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- University of Texas Southwestern Medical Center
Recurrent Ptosis of the Breast
Seri Surgical Scaffold Support of the Lower Pole of the Breast
Will the use of an FDA approved highly purified silk scaffold; Seri Surgical Scaffold help shape and hold the breast up on the chest preventing re-stretching and bottoming out of the breast in breast reduction or…
- Trial name
- SeriSupport (NCT02016612)
- Testing
- Seri Surgical Scaffold
- Where
- 2 sites in United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Bengtson Center
Pelvic Floor Disorders, Stress Urinary Incontinence
Educating Women About Pelvic Floor Disorders During Pregnancy
The purpose of this study is to assess the increase in knowledge of pregnant patients regarding pelvic floor disorders when comparing two educational interventions: written handouts vs interactive workshops.
- Conditions
- Pelvic Floor Disorders, Stress Urinary Incontinence, Pelvic Organ Prolapse
- Trial name
- NCT05440539
- Testing
- Written Handouts, Interactive Workshop
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- The Methodist Hospital Research Institute
Pelvic Organ Prolapse, Menopause
Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor
This is a study to determine how vaginal estrogen cream given for several weeks before pelvic reconstructive therapy will effect elastic fiber assembly in the muscularis layer of the vaginal wall.
- Trial name
- PET (NCT01778985)
- Testing
- Premarin
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Pelvic Organ Prolapse
Vaginally Assisted Laparoscopic Hysteropexy Versus Vaginal Hysterectomy
Utero-vaginal prolapse is a common, often disabling, condition experienced by women of varying ages. The traditional surgical treatment for utero-vaginal prolapse often includes vaginal hysterectomy and anterior or posterior…
- Trial name
- NCT03436147
- Testing
- POP-Q
- Where
- Turkey (Türkiye)
- Volunteers
- 49 people
- Sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Pelvic Organ Prolapse
Calistar A vs. Calistar S - Comparative Cohort Retrospective Analysis of Single Incision POP Systems
The main objective of this study is to compare the initial outcomes and complication of two meshes implanted through a single incision to treat anterior and apical prolapses, Calistar A and a second-generation low weight mesh…
- Trial name
- NCT03715803
- Testing
- Calistar A mesh to treat anterior and apical POP, Calistar S mesh to treat anterior and apical POP
- Where
- Argentina
- Volunteers
- 217 people
- Sponsor
- Agustin Sampietro
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
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, Urinary Incontinence
Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures
This is a randomized controlled trial to determine if there is a difference between chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery post operative infections.
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence, Pelvic Floor Disorders, Gynecologic Disease
- Trial name
- CLNUP (NCT04048356)
- Testing
- Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
- Where
- United States
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- University of New Mexico
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
Vaginal Hysterectomy, Laparoscopic Supracervical Hysterectomy
Vaginal Hysterectomy vs Supracervical Hysterectomy at the Time of Sacrocolpopexy
The primary objective of the proposed study is to determine the difference in surgical time between minimally invasive (laparoscopic) sacrocolpopexy performed with concurrent vaginal hysterectomy versus laparoscopic supracervical…
- Trial name
- ColoplastLSC (NCT04797585)
- Testing
- Laparoscopic supracervical hysterectomy, Vaginal hysterectomy
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- The Cleveland Clinic
Postoperative Pain, Opioid Use
STandard Versus No Opioid Prescription After Prolapse and Anti-INcontinence Surgery Trial
Overprescribing opioids is considered a major contributor to the opioid crisis. Hill et al. demonstrated that within a general surgery practice, over 70% of the prescribed opioid pills were never taken.
- Conditions
- Postoperative Pain, Opioid Use, Prolapse; Female, Incontinence
- Trial name
- STOP-PAIN (NCT04491617)
- Testing
- Standard opioid prescribing, Restrictive opioid prescribing
- Where
- United States
- Volunteers
- 129 people
- Sponsor
- The Cleveland Clinic