← Back to Search

Biologic Mesh

Subjects undergoing a pelvic organ prolapse repair procedure using Axis Dermis biologic mesh for Pelvic Organ Prolapse

Phase 4

Waitlist Available

Led By Salil Khandwala, MD

Research Sponsored by Michigan Institution of Women's Health PC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with preoperative stage II or greater prolapse on the Pelvic Organ Prolapse Quantification System Assessment (POP-Q)

Subjects who undergo any type of Axis Dermis surgery (anterior, posterior, total, with or without a uterus)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up preoperative to 3 years postoperative.

Awards & highlights

Study Summary

This trial aims to see if Axis Dermis, a type of biologic mesh, can help improve pelvic organ prolapse in participants. They will check if the prolapse is above the hymen and

Who is the study for?

This trial is for individuals experiencing pelvic organ prolapse, where organs like the bladder or uterus drop from their normal position. Participants should notice a bulge or have the leading edge of the prolapse above the hymen. Details on who can't join are not provided.Check my eligibility

What is being tested?

The study is testing Axis Dermis, a biologic mesh repair procedure for those with pelvic organ prolapse. It aims to see if this treatment improves conditions by keeping organs in place and reducing symptoms like bulging.See study design

What are the potential side effects?

Specific side effects are not listed, but generally, surgical procedures may include risks such as infection, bleeding, pain at the site of surgery, and possible reactions to materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My pelvic organ prolapse is stage II or higher.

Select...

I have had surgery involving the skin layer near my spine.

Select...

I feel a bothersome bulge in my vagina.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ preoperative to 3 years postoperative.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~preoperative to 3 years postoperative.

This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperative to 3 years postoperative. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Improvement in Anatomy

Improvement in function

Secondary outcome measures

Assess complications or untoward side effects.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Subjects undergoing a pelvic organ prolapse repair procedure using Axis Dermis biologic meshExperimental Treatment1 Intervention

This is a single are which will be composed of subjects with Stage II or greater pelvic organ prolapse who have agreed to undergoing a pelvic organ prolapse repair procedure using Axis Dermis biologic mesh. They will undergo the procedure and be followed for a period of 3 years.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Coloplast A/SIndustry Sponsor

153 Previous Clinical Trials

14,639 Total Patients Enrolled

6 Trials studying Pelvic Organ Prolapse

1,346 Patients Enrolled for Pelvic Organ Prolapse

Michigan Institution of Women's Health PCLead Sponsor

7 Previous Clinical Trials

341 Total Patients Enrolled

2 Trials studying Pelvic Organ Prolapse

110 Patients Enrolled for Pelvic Organ Prolapse

Salil Khandwala, MDPrincipal InvestigatorMichigan Institution of Women's Health PC

2 Previous Clinical Trials

117 Total Patients Enrolled

1 Trials studying Pelvic Organ Prolapse

30 Patients Enrolled for Pelvic Organ Prolapse

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to participate in this research study?

"Candidates aged between 21 and 89 who are diagnosed with pelvic organ prolapse are eligible for inclusion in this study, which aims to enroll approximately 50 participants."

Answered by AI

Are there ongoing efforts to actively enroll participants for this clinical trial?

"As per clinicaltrials.gov, recruitment for this trial is currently closed. The initial posting date was November 2nd, 2021, with the latest update on February 9th, 2024. However, individuals interested in participating can explore among the active enrollment of participants across a total of 85 other ongoing studies."

Answered by AI

Is the trial open to individuals who are younger than 85 years old?

"This research project is open to individuals over 21 years of age but under the age of 89."

Answered by AI

Do patients receiving a pelvic organ prolapse repair surgery with Axis Dermis biologic mesh have FDA authorization?

"Based on our assessment at Power, the safety rating for individuals undergoing pelvic organ prolapse repair with Axis Dermis biologic mesh in this Phase 4 study is graded as a 3 due to treatment approval."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Salil Khandwala 2021. "Axis(TM) Solvent-dehydrate Dermal Allograft in the Treatment of Pelvic Organ Prolapse.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06263985.