Gastric Restriction Using the EndoSurgical Operating System

August 7, 2012 updated by: USGI Medical
The primary objective is to collect data on the use of the EndoSurgical Operating System (EOS) for gastric tissue approximation during primary gastric restrictive procedures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico
        • Mexico
  • United States
    • Kentucky
      • Lexington, Kentucky, United States
        • Bluegrass
    • Louisiana
      • New Orleans, Louisiana, United States
        • SSL
    • Massachusetts
      • Boston, Massachusetts, United States
        • Brigham & Womens
    • North Carolina
      • Charlotte, North Carolina, United States
        • Presbyterian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient has met diabetic lab testing and all pre-procedural qualifications as delineated below.
  • Patient is >/= 20 yrs. of age and </= 60 yrs. of age
  • Patient has a BMI of >/=30 and < 40
  • Patient has history of obesity for >/= 2 yrs.
  • Patient has had not significant weight change (<5% of total body weight) in last 6 months.
  • Patient is a reasonable candidate for general anesthesia
  • Patient agrees not to have any additional weight loss surgery or liposuction for 2 yrs. following procedure.

Exclusion Criteria:

  • Patient is not able and willing to return for all follow-up evaluations, tests and nutritional counseling.
  • Patient is not able to provide written informed consent
  • Patient has history or present use of insulin or insulin derivatives for treatment of diabetes.
  • Patient has diabetes secondary to a specific disease.
  • Patient has history of inflammatory disease of GI tract
  • Patient has diabetic retinopathy
  • Patient has chronic pancreatic disease
  • Patient ahs active peptic ulcer
  • Patient has portal hypertension
  • Patient has esophageal varices
  • Patient has significant esophageal disease
  • Patient has a history of any significant abdominal surgery
  • Patient has a history of any bariatric or GERD surgical procedures
  • Patient has a hiatal hernia > 2cm.
  • Patient has esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments
  • Patient is of childbearing age and not practicing effective birth control method, pregnant or lactating.
  • Patient has had a MI or CVA in last year, or has unstable cardiovascular disease.
  • Patient has cancer or life expectancy of < 2 yrs.
  • Patient currently uses or has used over the counter or prescription weight loss drugs in last month or intends to use during follow-up Registry period.
  • Patient has quit smoking within last 6 months or plans to quit smoking in the next year.
  • Patient has a history of durg or alcohol abuse
  • Patient has uncontrolled depression, psychosis, or eating disorder.
  • Patient is non-ambulatory or has significant impairment of mobility.
  • Patient has known hormonal or genetic cause for obesity.
  • Patient is participating in another Registry and/or Study that could adversely affect this Registry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EOS
Collecting data on the use of the EOS for gastric tissue approximation during primary gastric restrictive procedures
Device: Using the EOS for gastric restriction

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Clinical Evaluation in regards to Weight Loss
Time Frame: 24 Months Post-op
24 Months Post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
USGI Medical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael J. Thomas, MD, FACS, SSL
  • Principal Investigator: Thomas Lavin, MD, SSL
  • Principal Investigator: David Voelinger, MD, Presbyterian
  • Principal Investigator: Peter Denk, MD, Bluegrass
  • Principal Investigator: Christopher Thompson, MD, Brigham & Womans
  • Principal Investigator: Santiago Horgan, MD, UCSD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TPR41122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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