TiLLT: Transmitted Light Tissue Thickness Analysis (TiLTT)

• Sponsor: Maimonides Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02749201
• Collaborator: Medtronic (Industry)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

To assess gastric wall thickness using transmitted light intensity.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity	Device: Gastrisail	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Transmitted Light Tissue Thickness Analysis (TiLTT)
• Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Analysis Light Intensity and gastric wall thickness analysis	Device: Gastrisail; Light Intensity and gastric wall thickness assessment

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Transmitted Light Intensity to Gastric Wall Thickness) [intraoperative]

   Number of patients with transmitted light intensity to gastric wall thickness between the groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maimonides Medical Center	Brooklyn	New York	United States	11219

Sponsors and Collaborators

• Maimonides Medical Center
• Medtronic

Investigators

• Principal Investigator: Danny Sherwinter, MD, Maimonides Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 15, 2015

More Information

Publications

None provided.

• Responsible Party: Danny A Sherwinter, Chief Minimally Invasive Surgery, Maimonides Medical Center
• ClinicalTrials.gov Identifier: NCT02749201
• Other Study ID Numbers: 2015-06-15-MMC
• First Posted: Apr 22, 2016
• Last Update Posted: Jun 23, 2021
• Last Verified: Jun 1, 2021

• Keywords provided by Danny A Sherwinter, Chief Minimally Invasive Surgery, Maimonides Medical Center: Obesity; sleeve gastrectomy
• Additional relevant MeSH terms: Obesity, Morbid

Study Results

Participant Flow

Arm/Group Title	Analysis
Arm/Group Description	Light Intensity and gastric wall thickness analysis Gastrisail: Light Intensity and gastric wall thickness assessment
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Analysis
Arm/Group Description	Light Intensity and gastric wall thickness analysis Gastrisail: Light Intensity and gastric wall thickness assessment
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 90%
>=65 years	1 10%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.9 (13.5)
Sex: Female, Male (Count of Participants)
Female	8 80%
Male	2 20%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	10 100%
Region of Enrollment (participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Analysis
Arm/Group Description	Light Intensity and gastric wall thickness analysis Gastrisail: Light Intensity and gastric wall thickness assessment
Measure Participants	10
Count of Participants [Participants]	10 100%

Adverse Events

Time Frame	Intraoperative only
Arm/Group Title	Analysis
Arm/Group Description	Light Intensity and gastric wall thickness analysis Gastrisail: Light Intensity and gastric wall thickness assessment
All Cause Mortality
	Analysis
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Analysis
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Analysis
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.