NCT02749201

Brief Summary

To assess gastric wall thickness using transmitted light intensity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

May 20, 2020

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

April 20, 2016

Results QC Date

November 14, 2018

Last Update Submit

June 22, 2021

Conditions

Morbid Obesity

Keywords

Obesitysleeve gastrectomy

Outcome Measures

Primary Outcomes (1)

  • 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

    intraoperative

Study Arms (1)

Analysis

EXPERIMENTAL

Light Intensity and gastric wall thickness analysis

Device: Gastrisail

Interventions

GastrisailDEVICE

Light Intensity and gastric wall thickness assessment

Analysis

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Revisional Bariatric Surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Obesity, MorbidObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Danny Sherwinter
Organization
maimonides medical center
dsherwinter@maimonidesmed.org
7182837952

Study Officials

  • Danny Sherwinter, MD

    Maimonides Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Minimally Invasive Surgery

Study Record Dates

First Submitted

April 20, 2016

First Posted

April 22, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

June 23, 2021

Results First Posted

May 20, 2020

Record last verified: 2021-06

Locations

US(1)