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Axis(TM) Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse.

NCT06263985 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-02-16

No results posted yet for this study

Summary

The goal of this study is to assess improvement in subjects who have undergone Axis Dermis, biologic mesh for pelvic organ prolapse repair. \[describe participant population/health conditions\]. The main question\[s\] it aims to answer are:

* Is the leading edge of the prolapse above the hymen
* Does subject notice a bulge Participants will undergo Axis Dermis pelvic organ prolapse repair procedure.

Conditions

  • Pelvic Organ Prolapse

Interventions

DEVICE

Axis Dermis biologic mesh repair for pelvic organ prolapse

Subjects with pelvic organ prolapse will undergo a pelvic organ prolapse repair with the use of Axis Dermis biologic mesh.

Sponsors & Collaborators

  • Coloplast A/S

    collaborator INDUSTRY

  • Michigan Institution of Women's Health PC

    lead OTHER

Principal Investigators

  • Salil Khandwala, MD · Michigan Institution of Women's Health PC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
89 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2025-05-30
Completion
2025-05-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06263985 on ClinicalTrials.gov