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Pilot Study of the Endolumik Gastric Calibration Tube for Bariatric Surgery
The pilot study will be a First In Human Clinical Trial to evaluate the Endolumik Gastric Calibration Tube and associated methods in a human clinical cohort of 20-30 bariatric patients at two high-volume bariatric programs. During this clinical study, the single-use, disposable Endolumik Gastric Calibration Tube will be used during twenty sleeve gastrectomy operations and gastric bypass operations.
Conditions:
🦠 Morbid Obesity
🗓️ Study Start (Actual) August 2022
🗓️ Primary Completion (Estimated) November 2022
✅ Study Completion (Estimated) December 2022
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Morgantown, West Virginia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * English speaking
    • * Adults (between age of 18 and 65 years old)
    • * Have body mass index (BMI) between 35 and 65.99 kg/m2
    • * Male or female bariatric patients undergoing bariatric surgery at one of the two sites included in the protocol.

    Exclusion Criteria:

    • * Nonbariatric patients
    • * Patients who have conditions that preclude a sleeve gastrectomy or gastric bypass operation
    • * Patients with esophageal stricture
    • * Patients with esophageal varices
    • * Patients with a Zenker's diverticulum
    • * Patients aged 66 and older
    • * Patients with a BMI of 66 kg/m2 or greater
    • * Pregnant Women
    • * Lactating Women
    • * Other vulnerable patient populations: pregnant and lactating women, prisoners, cognitively impaired and critically ill subjects.
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
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 1 August 2022
  • First Submitted that Met QC Criteria 1 August 2022
  • First Posted 3 August 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 August 2022
  • Last Update Posted 3 August 2022
  • Last Verified August 2022
I'm interested ...!!