Pilot Study of the Endolumik Gastric Calibration Tube for Bariatric Surgery

Morbid Obesity Clinical Trial

Official title:

Pilot Study of the Endolumik Gastric Calibration Tube for Bariatric Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05486325
• Other study ID #: Pro00058006
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2022
• Est. completion date: December 2022

Study information

• Verified date: August 2022
• Source: Endolumik, Inc
• Contact: Mara McFadden
• Phone: 5104684426
• Email: mcfadden[@]endolumik.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Endolumik Inc. has developed a fluorescence-guided calibration device, the Endolumik Gastric Calibration Tube, to improve visualization during bariatric operations. The present 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. The goal of the present study is to 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 submitting a 510(k) application to the U.S. Food and Drug Administration (FDA).

In this multicenter trial, both study sites are certified as Bariatric Centers of Excellence through the American Society of Metabolic and Bariatric Surgery. The first clinical site is Ruby Memorial Hospital, part of West Virginia University; the second clinical site is Durham Regional Hospital, part of Duke University.

To date, using funding from a West Virginia Clinical & Translational Science Institute Launch Pilot Grant, our team has validated the device and associated methods of fluorescence-guided sleeve gastrectomy and fluorescence-guided gastric bypass in ex-vivo and in-vivo porcine models, as well as human cadaveric tissue models. Based on FDA criteria, this investigational device meets the definition of a Non-Significant Risk (NSR) device; the risk classification document is included with submission materials.

The investigational device provided will have met design controls per FDA code of federal regulation (CFR): 21 CFR 820.30. Endolumik Inc. will serve as the industry sponsor for this study and will donate the devices being used for the protocol to the two participating study sites. Development of the technology in this research is supported by the West Virginia University Department of Surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

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.

Locations

Country	Name	City	State
United States	West Virginia University	Morgantown	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Endolumik, Inc	West Virginia University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative adverse events	Adverse events occurring during surgical treatment	During surgical treatment
Primary	Operative time	Duration of surgical treatment	During surgical treatment
Primary	30-day morbidity	any 30-day Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) Occurrences	30 days post surgical treatment

External Links

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