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Traxi Panniculus Retractor for Cesarean Delivery

NCT03651076 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2025-02-10

No results posted yet for this study

Summary

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.

Conditions

  • Obesity, Morbid
  • Cesarean Section Complications

Interventions

DEVICE

Traxi panniculus retraction (Clinical Innovations, LLC)

class I, FDA-exempt, commercially available for use in panniculus retraction during cesarean delivery or other laparotomy

Sponsors & Collaborators

Principal Investigators

  • Ai-ris Collier, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-02
Primary Completion
2025-02-01
Completion
2025-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03651076 on ClinicalTrials.gov