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NCT02248935 · ClinicalTrials.gov registry record

Comparison of 2 Lightweight Y-meshes After Laparoscopic Sacrocolpopexy

A clinical trial of Pelvic Organ Prolapse, sponsored by Atlantic Health System.

Completed
Registry status
316
Enrollment target
1
Study location

NCT02248935: Completed study of Pelvic Organ Prolapse, sponsored by Atlantic Health System.

NCT02248935 is a study of Pelvic Organ Prolapse that has completed, run by Atlantic Health System. The registered enrollment target is 316 participants, above the 137-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (131% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02248935, a study of Pelvic Organ Prolapse, has completed, sponsored by Atlantic Health System.

COMPLETED
Registry status
316 participants
Enrollment target
1
Study location

Study Summary

The purpose of the study is to determine the clinical cure rates of pelvic organ prolapse from subjects that had a robotic-assisted sacrocolpopexy using Alyte Y mesh and Restorelle Y smartmesh lightweight mesh.

Primary Outcome

To be considered a "clinical cure" subjects must meet all of the following criteria: no re-operation for or non-surgical treatment of pelvic organ prolapse since the index surgery; no symptoms of vaginal bulge as measured by a validated symptom questionnaire; no Pelvic Organ Prolapse Quantification (POP-Q) points greater than 0; POP-Q point C less than or equal to -5; an answer of "satisfied" or "very satisfied" on validated Surgical Satisfaction Questionnaire

Conditions Studied

Study Locations (1)

New Jersey

  • Department of Urogynecology-Atlantic Health System - Morristown

Trial Details

FieldValue
Enrollment Target 316 participants
Start Date 2014-07
Est. Completion 2015-08
Atlantic Health System

43 total trials

What the finished NCT02248935 record still lists

NCT02248935 is an observational study that tracks outcomes without assigning an intervention. The registered 316 participants enrollment target is mid-sized for trials with a published cap, above the 137-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (131% higher).

The record links to 1 condition, with Pelvic Organ Prolapse appearing as the primary indexed condition, and to 0 interventions.

NCT02248935 reports a single indexed study location in New Jersey.

Frequently Asked Questions

What is clinical trial NCT02248935 about?

NCT02248935 is a clinical study titled "Comparison of 2 Lightweight Y-meshes After Laparoscopic Sacrocolpopexy". The purpose of the study is to determine the clinical cure rates of pelvic organ prolapse from subjects that had a robotic-assisted sacrocolpopexy using Alyte Y mesh and Restorelle Y smartmesh lightweight mesh.

What is the current status of trial NCT02248935?

This trial is currently completed. The enrollment target is 316 participants. The study started on 2014-07. Estimated completion is 2015-08.

What conditions does trial NCT02248935 study?

This clinical trial studies the following conditions: Pelvic Organ Prolapse.

Who is sponsoring clinical trial NCT02248935?

This trial is sponsored by Atlantic Health System, which has 43 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02248935 being conducted?

This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Pelvic Organ Prolapse

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02248935's enrollment target sits among peer trials

316 3rd of 40 higher than 38 of 40 other Pelvic Organ Prolapse trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pelvic Organ Prolapse trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02248935, the US trial registry maintained by the National Library of Medicine. NCT02248935 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.