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New device aims to make C-Sections safer for obese mothers

NCT ID NCT03651076

Symptom relief Sponsor: Beth Israel Deaconess Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 study tested a special device called the Traxi panniculus retractor, which holds excess belly tissue out of the way during cesarean deliveries. The goal was to see if it could shorten surgery time, improve breathing, and increase satisfaction for both patients and doctors. The trial included 142 pregnant women with a BMI of 40 or higher who were having a planned C-section. However, the study was stopped early, so the full results are not available.

What this could mean

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

Active substance
Traxi panniculus retractor (a medical device that holds excess belly tissue out of the way during surgery)
What this could lead to
If successful, this device could make C-sections faster and safer for women with obesity, and improve their breathing and comfort during the procedure.
What could go wrong
The trial was terminated early, so results are limited. The device is already available, but its benefits over standard methods are not proven.

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

142 people

The number who actually took part.

Started

Oct 2018

Finished

Feb 2025

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 50 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: * Pregnant * BMI greater than or equal to 40 kg/m\^2 * Undergoing non-emergent cesarean delivery * Able and willing to provide written, informed consent * Singleton gestation Exclusion Criteria: * Fetal demise * Disruption of abdominal skin (infection, rash, abrasion, laceration) * Known adhesive allergy

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Conditions

The condition(s) this trial relates to.

morbid obesity

As listed by the trial registrant

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

Cesarean section complications Obesity, morbid

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

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