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NCT01541748 · ClinicalTrials.gov registry record

Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study

A clinical trial of Pelvic Organ Prolapse, sponsored by Coloplast A/S.

Completed
Registry status
74
Enrollment target
5
Study locations

NCT01541748 is a study of Pelvic Organ Prolapse that has completed, run by Coloplast A/S. The registered enrollment target is 74 participants, below the 143-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (48% lower). The trial reports 5 study locations across 4 states.

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The verdict

NCT01541748, a study of Pelvic Organ Prolapse, has completed, sponsored by Coloplast A/S.

COMPLETED
Registry status
74 participants
Enrollment target
5
Study locations

Study Summary

This study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.

Conditions Studied

Pelvic Organ Prolapse

Interventions

  • OTHER Axis

Study Locations (5)

Pennsylvania

  • The Institute for Female Pelvic Medicine and Reconstructive Surgery - Allentown
  • Philadelphia Urosurgical Associates - Philadelphia

Florida

  • Cleveland Clinic Florida - Weston

Massachusetts

  • Boston Urogynecology Associates - Cambridge

Michigan

  • Female Pelvic Medicine and Urogynecology Institute of MI/Grand Rapids Women's Health - Grand Rapids

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2011-11
Est. Completion 2018-11-11

Sponsor

Coloplast A/S

21 total trials

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What the Registry Record Tells You About NCT01541748

The ClinicalTrials.gov registry entry for NCT01541748 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 143-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (48% lower). The listed sponsor is Coloplast A/S, which has 21 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pelvic Organ Prolapse appearing as the primary indexed condition, and to 1 intervention - of which Axis is the first listed.

NCT01541748 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Pennsylvania, Florida, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01541748 about?

NCT01541748 is a clinical study titled "Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study". This study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.

What is the current status of trial NCT01541748?

This trial is currently completed. The enrollment target is 74 participants. The study started on 2011-11. Estimated completion is 2018-11-11.

What conditions does trial NCT01541748 study?

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

What interventions are being tested in trial NCT01541748?

The interventions under investigation include: Axis (OTHER).

Who is sponsoring clinical trial NCT01541748?

This trial is sponsored by Coloplast A/S, which has 21 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01541748 being conducted?

This trial has 5 study locations across Florida, Massachusetts, Michigan, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.