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Transmitted Light Tissue Thickness Analysis (TiLTT) (TiLLT)

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gastrisail
Sponsored by
Maimonides Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Morbid Obesity focused on measuring Obesity, sleeve gastrectomy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject has provided informed consent
  • Subject is between the ages of 18 and 80 years of age
  • Subject is scheduled for and undergoes primary sleeve gastrectomy

Exclusion Criteria:

  • Revisional Bariatric Surgery

Sites / Locations

  • Maimonides Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Analysis

Arm Description

Light Intensity and gastric wall thickness analysis

Outcomes

Primary Outcome Measures

Number of Patients With Transmitted Light Intensity to Gastric Wall Thickness)
Number of patients with transmitted light intensity to gastric wall thickness between the groups

Secondary Outcome Measures

Full Information

First Posted
April 20, 2016
Last Updated
June 22, 2021
Sponsor
Maimonides Medical Center
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT02749201
Brief Title
Transmitted Light Tissue Thickness Analysis (TiLTT)
Acronym
TiLLT
Official Title
Transmitted Light Tissue Thickness Analysis (TiLTT)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maimonides Medical Center
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To assess gastric wall thickness using transmitted light intensity.
Detailed Description
The most common surgical procedure for weight loss is the sleeve gastrectomy. The laparoscopic sleeve gastrectomy (LSG) involves the linear stapling of the stomach using a stapling device [e.g. Echelon (Ethicon Somerset NJ)] fired multiple times along the length of the stomach thereby excising 80-90% of the stomach leaving the patient with a "sleeve" of stomach rather than the normal anatomical pouch. The gastric wall varies in thickness and thus there are a varied staple sizes available for this use. Staple sizes range from 2.0mm-5.0mm in height. In standard surgical practice the surgeon chooses the size of staple cartridge for each subsequent firing based on his experience and estimations about the thickness of the stomach tissue in any given region. The drawback of this technique is that it is highly inaccurate. If the surgeon's estimation is in error, the staple height chosen may be either too tall or too short leading to bleeding or leakage from between the staples or malformed/unformed staples leading to staple line failure. Any of these errors can lead to devastating complications such as hemorrhage, leak, sepsis and death. To date there is no objective way to measure the thickness of the tissue being stapled and thus staple choice relies entirely on surgeon estimation which is inherently inaccurate. The investigators hypothesize that a light source placed in the stomach lumen will transmit light through the gastric wall. The amount of light transmitted, i.e. visible to an imaging device arrayed external to the stomach, will be directly proportionate to the thickness of the stomach. This study will take advantage of the fact that during routine procedures in the sleeve gastrectomy procedure a lighted tube is placed into the gastric lumen via the mouth. This device is called the Gastrisail and has 10 separate LED lights arrayed along its length. This allows for the measurement of transmitted light intensity through the gastric wall at 10 individual locations along the length f the stomach. In addition this study will take advantage of the fact that during standard practice in a sleeve gastrectomy a section of the stomach corresponding to the location of the lights is excised and sent for pathological evaluation. This will allow us to measure the actual thickness of the stomach at 10 points corresponding to he locations of the transmitted light intensity. For this measurement The investigators will use a standardized and validated measurement tool/calipers. Now with two sets of numbers the investigators plan to correlate the degree of transmitted light intensity with actual thickness measurements and thereby reach an algorithm which will allow the transmitted light intensity data alone to predict gastric wall thickness. This will provide the surgeon with an entirely non-invasive objective measure of gastric wall thickness and hopefully improve his/her choice of staple size during these surgical procedures thus improving safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Obesity, sleeve gastrectomy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Analysis
Arm Type
Experimental
Arm Description
Light Intensity and gastric wall thickness analysis
Intervention Type
Device
Intervention Name(s)
Gastrisail
Intervention Description
Light Intensity and gastric wall thickness assessment
Primary Outcome Measure Information:
Title
Number of Patients With Transmitted Light Intensity to Gastric Wall Thickness)
Description
Number of patients with transmitted light intensity to gastric wall thickness between the groups
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has provided informed consent Subject is between the ages of 18 and 80 years of age Subject is scheduled for and undergoes primary sleeve gastrectomy Exclusion Criteria: Revisional Bariatric Surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danny Sherwinter, MD
Organizational Affiliation
Maimonides Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States

12. IPD Sharing Statement

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Transmitted Light Tissue Thickness Analysis (TiLTT)

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