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Pilot Study of the Endolumik Gastric Calibration Tube for Bariatric Surgery

NCT05486325 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-08-03

No results posted yet for this study

Summary

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

Interventions

DEVICE

Endolumik Gastric Calibration Tube (EGCT)

Up to twenty participants will undergo laparoscopic or robotic sleeve gastrectomy using the EGCT. This operation will take approximately 60 minutes. The portions of the sleeve gastrectomy operation where the EGCT will be used include: * To evacuate gastric contents * During construction of the gastric sleeve * To perform the leak test of the gastric sleeve Up to ten participants will undergo laparoscopic gastric bypass using the EGCT. This operation will take approximately 120 minutes. The portions of the gastric bypass operation where the EGCT will be used include: * To evacuate gastric contents * During construction of the gastric pouch * To calibrate closure of the gastrojejunal anastomosis * To perform a leak test of the gastrojejunal anastomosis In both procedures, The amount of time the EGCT will be inside the patient is approximately 20 minutes. The device is removed prior to the conclusion of the operation, while the patient is under anesthesia.

Sponsors & Collaborators

  • West Virginia University

    collaborator OTHER

  • Endolumik, Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2022-11-30
Completion
2022-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05486325 on ClinicalTrials.gov