RECRUITING
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Traxi Panniculus Retractor for Cesarean Delivery
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
🗓️ Study Start (Actual) 2 October 2018
🗓️ Primary Completion (Estimated) January 2025
✅ Study Completion (Estimated) May 2025
👥 Enrollment (Estimated) 240
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 50 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 July 2018
  • First Submitted that Met QC Criteria 27 August 2018
  • First Posted 29 August 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 January 2024
  • Last Update Posted 19 January 2024
  • Last Verified January 2024
I'm interested ...!!