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Transmitted Light Tissue Thickness Analysis (TiLTT)

Transmitted Light Tissue Thickness Analysis (TiLTT)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02749201
Acronym
TiLLT
Enrollment
10
Registered
2016-04-22
Start date
2016-04-30
Completion date
2017-04-30
Last updated
2021-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Keywords

Obesity, sleeve gastrectomy

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.

Interventions

DEVICEGastrisail

Light Intensity and gastric wall thickness assessment

Sponsors

Medtronic
CollaboratorINDUSTRY
Maimonides Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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

Design outcomes

Primary

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

Countries

United States

Participant flow

Participants by arm

ArmCount
Analysis
Light Intensity and gastric wall thickness analysis Gastrisail: Light Intensity and gastric wall thickness assessment
10
Total10

Baseline characteristics

CharacteristicAnalysis
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
1 Participants
Age, Categorical
Between 18 and 65 years
9 Participants
Age, Continuous45.9 years
STANDARD_DEVIATION 13.5
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
10 Participants
Race (NIH/OMB)
White
0 Participants
Region of Enrollment
United States
10 participants
Sex: Female, Male
Female
8 Participants
Sex: Female, Male
Male
2 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 10
other
Total, other adverse events
0 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

Primary

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

Time frame: intraoperative

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
AnalysisNumber of Patients With Transmitted Light Intensity to Gastric Wall Thickness)10 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026