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New drain could speed recovery after breast reconstruction

NCT ID NCT05975359

Symptom relief Sponsor: Stanford University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests a new type of surgical drain called the Interi Manifold against the standard Jackson-Pratt drain in women having implant-based breast reconstruction after mastectomy. The new drain has multiple branches and a special suction system that may remove fluid more consistently. Researchers will compare safety, time to drain removal, number of drain sites, and patient satisfaction in 20 participants.

What this could mean

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

Active substance
Interi Manifold Drain System (device)
What this could lead to
If it works, this could reduce the number of drain sites and shorten recovery time for women undergoing breast reconstruction after mastectomy.
What could go wrong
This is a very small pilot study with only 20 participants, so results may not apply to everyone. The new drain could have similar or higher complication rates than standard drains.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

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

Started

Oct 2023

Expected to finish

Sep 2026

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 to 65 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Breast cancer diagnosis (any form) or Genetic mutation with presence of breast mass. 2. Indication for bilateral mastectomy 3. Plan for immediate, implant-based pre-pectoral breast reconstruction using an acellular dermal matrix 4. Age 18 - 65 5. Female Sex 6. Ability to understand and the willingness to personally sign the written IRB-approved informed consent document (English language). Exclusion Criteria: 1. Have a prior history of radiation to the breast or planned radiotherapy to the breast within the first year post-operatively. 2. Are enrolled in another study that requires the concomitant use of any investigational product during the study period that the Principal Investigator believes will interfere with study endpoints. 3. Have received oncologic chemotherapy within the past 21 days or planned within the time fame of the study intervention. Have received antiplatelet therapy (other than aspirin) and/ or other anticoagulation therapy in the past 60 days. 4. Are a smoker or use illicit drugs. 5. Any prior allergic reaction to Teflon. 6. Are pregnant or nursing. 7. Are undergoing a delayed reconstruction following mastectomy. 8. HIV infection, active UTI infection, or other active infection. 9. Those requiring more than one Manifold for fluid removal per breast will be excluded.

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Conditions

The condition(s) this trial relates to.

breast cancer

As listed by the trial registrant

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

Implant based breast reconstruction Mastectomy

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

  • Stanford Hospital and Clinics

    RECRUITING

    Palo Alto, California, 94304, United States

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