Morbid ObesityTiLLTNCT02749201
Transmitted Light Tissue Thickness Analysis (TiLTT)
A study testing Gastrisail in people with Morbid Obesity, run by Maimonides Medical Center at 1 site in United States.
Trial summary
To assess gastric wall thickness using transmitted light intensity. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Gastrisail
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Revisional Bariatric Surgery
Trial locations and contacts
1 site in 1 country.
About this study
To assess gastric wall thickness using transmitted light intensity.
Read the 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.
- Conditions
- Morbid Obesity
- Being tested
- Gastrisail
- Keywords
- Obesity, sleeve gastrectomy
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastrisailDevice
Light Intensity and gastric wall thickness assessment
| Study group | Role | What they receive |
|---|---|---|
| Analysis | Experimental | Light Intensity and gastric wall thickness analysis Receives: Device: Gastrisail |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Danny A Sherwinter, Maimonides Medical Center
- Investigators
- Danny Sherwinter, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749201
- Sponsor's protocol ID
- 2015-06-15-MMC
- Acronym
- TiLLT
- Status last verified
- Jun 2021
- First submitted
- 20 Apr 2016
- Last updated
- 23 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transmitted Light Tissue Thickness Analysis (TiLTT)
- ClinicalTrials.gov ID
- NCT02749201
- Acronym / sponsor ID
- TiLLT / 2015-06-15-MMC
- Conditions
- Morbid Obesity
- Keywords
- Obesity, sleeve gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Posted 20 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Analysis | Experimental | Device: GastrisailLight Intensity and gastric wall thickness analysis |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Revisional Bariatric Surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GastrisailLight Intensity and gastric wall thickness assessment | Device | Analysis |
Primary outcome
Number of Patients With Transmitted Light Intensity to Gastric Wall Thickness)
Time frame: intraoperative
Number of patients with transmitted light intensity to gastric wall thickness between the groups
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danny Sherwinter, MD principal investigator
Maimonides Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastrisail in people with Morbid Obesity, run by Maimonides Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Transmitted Light Intensity to Gastric Wall Thickness) (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.