Traxi Panniculus Retractor for Cesarean Delivery

Stopped early · Not applicable

Conditions studied: Obesity, Morbid, Cesarean Section Complications

In brief

This prospective, open-label, randomized-controlled trial is designed to evaluate the use of the Traxi panniculus retractor-- a commercially available Class I FDA-exempt device will improve surgical outcomes, cardiopulmonary function, and provider/patient satisfaction in morbidly obese women undergoing cesarean delivery.

Key facts

Study ID

NCT03651076

Run by

Beth Israel Deaconess Medical Center

People needed

142

Starts

2018-10-02

Expected to finish

2025-02-01

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Fetal demise
• Disruption of abdominal skin (infection, rash, abrasion, laceration)
• Known adhesive allergy

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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