Pilot Study of the Endolumik Gastric Calibration Tube for Bariatric Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2022-12-31

Brief Summary

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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.

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RECRUITING

Detailed Description

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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.

Conditions

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Morbid Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bariatric Surgery

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.

Group Type EXPERIMENTAL

Endolumik Gastric Calibration Tube (EGCT)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No