Pilot Study of the Endolumik Gastric Calibration Tube for Bariatric Surgery

NCT05486325 | Unknown DMC FDA Device

• 1 other identifier: Pro00058006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Intraoperative adverse events

  Adverse events occurring during surgical treatment

  During surgical treatment

• Operative time

  Duration of surgical treatment

  During surgical treatment

• 30-day morbidity

  any 30-day Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) Occurrences

  30 days post surgical treatment

Study Arms (1)

Bariatric Surgery

EXPERIMENTAL

Up to twenty participants meeting inclusion criteria will undergo laparoscopic or robotic sleeve gastrectomy using the Endolumik Gastric Calibration Tube instead of the standard bougie calibration tube. Up to ten participants meeting inclusion criteria will undergo laparoscopic gastric bypass using the Endolumik Gastric Calibration Tube instead of the standard calibration tube.

Device: Endolumik Gastric Calibration Tube (EGCT)

Interventions

Endolumik Gastric Calibration Tube (EGCT) DEVICE

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.

Bariatric Surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endolumik, Inc: lead
• West Virginia University: collaborator

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26505, United States

Location

Related Publications (3)

• English WJ, DeMaria EJ, Brethauer SA, Mattar SG, Rosenthal RJ, Morton JM. American Society for Metabolic and Bariatric Surgery estimation of metabolic and bariatric procedures performed in the United States in 2016. Surg Obes Relat Dis. 2018 Mar;14(3):259-263. doi: 10.1016/j.soard.2017.12.013. Epub 2017 Dec 16.

  PMID: 29370995 BACKGROUND

• Mahawar KK. Bougie-Related Oesophageal Injury with Bariatric Surgery: An Unrecognised Problem. Obes Surg. 2016 Aug;26(8):1935-6. doi: 10.1007/s11695-016-2213-1. No abstract available.

  PMID: 27129804 BACKGROUND

• Lovece A, Rouvelas I, Hayami M, Lindblad M, Tsekrekos A. Cervical esophageal perforation caused by the use of bougie during laparoscopic sleeve gastrectomy: a case report and review of the literature. BMC Surg. 2020 Jan 10;20(1):9. doi: 10.1186/s12893-020-0679-1.

  PMID: 31924187 BACKGROUND

Related Links

• Morbid Obesity Data
• Bariatric Surgery Data
• Fluorescence Guided Surgery

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mara McFadden

CONTACT

5104684426; mcfadden@endolumik.com

Nova Szoka, Dr.

CONTACT

13049067613; szoka@endolumik.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The sample size (n) will be 20-30 Bariatric patients. Twenty participants will undergo laparoscopic or robotic sleeve gastrectomy using the Endolumik Gastric Calibration Tube instead of the standard bougie calibration tube. Ten participants will undergo laparoscopic gastric bypass using the Endolumik Gastric Calibration Tube instead of the standard calibration tube. The current pilot protocol is a qualitative, not quantitative, study design, thus no power calculation is indicated. The goal of the present pilot study is to serve as the First In Human trial and confirm that the Endolumik Gastric Calibration Tube performs similar to predicate devices currently on the market, as well as to get end-user feedback prior to 510(k) application to the FDA. The sample size was chosen because 20 to 30 uses will allow the development team to appropriately evaluate device performance.

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 3, 2022
• Study Start: August 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)