Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03534830 · ClinicalTrials.gov registry record
A Novel Assay for Predicting Surgical Outcomes in Pelvic Organ Prolapse
A clinical trial, sponsored by University of South Florida.
- Completed
- Registry status
- 51
- Enrollment target
NCT03534830: Completed study, sponsored by University of South Florida.
NCT03534830 is a clinical trial that has completed, run by University of South Florida. The registered enrollment target is 51 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03534830 has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- 51 participants
- Enrollment target
Study Summary
The research objective of this proposal is to investigate the clinical utility and validity of eLASV as a personalized marker for women's individual risk of recurrence for pelvic organ prolapse following advanced surgical procedures. Estimated levator ani subtended volume (eLASV) is a reproducible magnetic resonance image of the female pelvis that objectively quantifies the integrity of the pelvic floor levator ani muscles. A woman's levator ani muscle anatomical shape is unique to her as a result of her own individual lifetime risk for development of pelvic floor dysfunction. The novelty of eLASV as a measurement of muscle integrity, separates it methodology from the solitary of diagnosing partial trauma or defects as previously published within the literature. eLASV measurements have the potential to identify women at increased risk for surgical failure and may be used as a prognostic tool to aid in future counseling and stratification of patients into surgical options for treatment of pelvic organ prolapse.
Primary Outcome
Surgical failure will be a single composite outcome that will be defined by any of the following information: presence of anatomic bulge beyond the hymen (within any compartment: anterior, posterior, or apical), sensation of a symptomatic vaginal bulge, or the need for repeat treatment for prolapse via pessary or surgery
Interventions
- DIAGNOSTIC_TEST MRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2018-02-02 |
| Est. Completion | 2021-01-01 |
What the finished NCT03534830 record still lists
NCT03534830 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 51 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which MRI is the first listed.
NCT03534830 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03534830 about?
NCT03534830 is a clinical study titled "A Novel Assay for Predicting Surgical Outcomes in Pelvic Organ Prolapse". The research objective of this proposal is to investigate the clinical utility and validity of eLASV as a personalized marker for women's individual risk of recurrence for pelvic organ prolapse following advanced surgical procedures. Estimated levator ani subtended volume (eLASV) is a reproducible m...
What is the current status of trial NCT03534830?
This trial is currently completed. The enrollment target is 51 participants. The study started on 2018-02-02. Estimated completion is 2021-01-01.
What interventions are being tested in trial NCT03534830?
The interventions under investigation include: MRI (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03534830?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02701153 · 51 participants · NA
Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort
- NCT03663790 · 51 participants · NA
Effects of Gait Retraining on Lower Extremity Biomechanics
- NCT03874052 · 51 participants · Phase 1
Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
- NCT04704661 · 51 participants · Phase 1
Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI