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Could amniotic membrane ease bladder pain? new trial seeks answers

NCT ID NCT06096597

Disease control Sponsor: David Sheyn Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests whether injecting a substance made from donated amniotic membrane into the bladder can reduce pain and urgency in women with interstitial cystitis (painful bladder syndrome). One hundred women who have not gotten better with other treatments will receive either the amniotic membrane injection or a placebo (salt water). The main goal is to see if symptoms improve significantly over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
micronized amniotic membrane (Clarix Flo)
What this could lead to
If it works, this could offer a new treatment option for women with painful bladder syndrome who haven't improved with other therapies.
What could go wrong
This is an early combined phase 2/3 trial with only 100 participants, so results may not be conclusive. The treatment is injected directly into the bladder, which carries risks of infection or discomfort.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients 18 years of age or older * Female * English Speaking * Diagnosis of IC/PBS * Have failed at least one prior treatment for IC/PBS Exclusion Criteria: * Patients less than 18 years of age * Unable to provide consent * Non-English speaking * Patients with known anatomical malformations of the ureters, bladder, or urethra

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Conditions

The condition(s) this trial relates to.

interstitial cystitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Interstitial cystitis Painful bladder syndrome Painful bladder syndrome (PBS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospitals

    RECRUITING

    Clevleand, Ohio, 44106, United States

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