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Biologic Mesh

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)

Must not have

Subjects who decline to be part of the clinical trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up preoperative to 3 years postoperative.

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I choose not to participate in the clinical trial.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement in Anatomy

Improvement in function

Secondary study objectives

Assess complications or untoward side effects.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 4Eligibility criteria met