The USGI Medical ESSENTIAL Study for Weight Loss

March 31, 2017 updated by: USGI Medical

A RANDOMIZED, SUBJECT AND EVALUATOR-BLINDED, PARALLEL-GROUP, MULTICENTER CLINICAL TRIAL USING AN ENDOSCOPIC SUTURING DEVICE (G-CATH EZ™ SUTURE ANCHOR DELIVERY CATHETER) FOR PRIMARY WEIGHT LOSS

This is a multicenter, randomized, evaluator and subject blinded, parallel-group, controlled study intended to evaluate the safety and efficacy of treating obese patients with the placement of g-Cath EZ suture anchors followed by a structured diet and exercise plan as compared to a sham procedure followed by the same diet and exercise plan. Subjects will be randomly assigned in a 2:1 ratio to the treatment procedure followed by diet and exercise or the sham procedure followed by diet and exercise. After un-blinding at 12 months post-treatment, sham patients can choose to have the treatment procedure as well.

Study Overview

Status

Status

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

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.
377

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

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Scottsdale Healthcare
    • Florida
      • Miami, Florida, United States, 33166
        • DeWitt Daughtry Family Department of Surgery University of Miami Miller School of Medicine
    • Georgia
      • Dalton, Georgia, United States, 30722
        • Hamilton Medical Center
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Northshore University Healthsystem
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Crescent City Surgical Centre
    • Massachusetts
      • Boston, Massachusetts, United States, 02120
        • Brigham & Women's Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of MN, Fairview Health Services
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Lexington Medical Center
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial

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

22 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Provide written informed consent.
  2. Be male or female subjects between the ages of 22-60 years.
  3. If female, be either post-menopausal, surgically sterile or agree to practice birth control during year of study and have negative serum HCG at screening and baseline.
  4. Have a Body Mass Index (BMI) of ≥30 and <35 with at least one non-severe co-morbid obesity related condition or a BMI ≥ 35 and < 40 with or without a non-severe obesity related co-morbid condition, where a severe co-morbid condition is defined as severe if symptoms cause severe discomfort, performance of daily activities is compromised, and/or condition is not entirely controlled with prescription drug therapy.
  5. Have had no significant weight change (+/- 5% of total body weight) in last 6 months.
  6. Have an American Society Anesthesiologists-PS score ≤ 2 (Appendix III).
  7. Agrees not to have any additional weight loss interventional procedures, liposuction, or take any over the counter or prescription weight loss medication for 24 months following study enrollment.
  8. Have not taken any prescription or over the counter weight loss medications for at least 6 months and agrees not to utilize for 12 months following study enrollment.
  9. Be willing to cooperate with post-operative dietary recommendations and assessment tests.
  10. Reside within a reasonable distance from the Investigator's treating office (~50 miles) and able and willing to travel to the Investigator's office to complete all routine follow-up visits.

Exclusion Criteria:

  1. History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.
  2. Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments.
  3. Severe gastro-esophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with prescription drug therapy.
  4. Large hiatal hernia (>3 cm) by history or as determined by pre-randomization endoscopy.
  5. Pancreatic insufficiency/disease.
  6. Active gastric erosions or gastric/duodenal ulcer.
  7. History of gastroparesis or symptoms that would be suggestive of gastroparesis.
  8. Pregnancy or plans of pregnancy in the next 12 months.
  9. Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 1 month of Visit 1. Intranasal/inhaled steroids are acceptable.
  10. History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis
  11. History or present use of insulin or insulin derivatives for treatment of diabetes
  12. Type II Diabetes Mellitus (as defined by HgbA1c >6.5%) for greater than 10 years at the time of enrollment
  13. Quit smoking within the last 6 months at time of enrollment or plans to quit smoking in the year after enrollment
  14. Portal hypertension and/or varices.
  15. Gastric outlet obstruction or stenosis.
  16. Significant abnormality identified during Visit 2 (randomization visit) with endoscopy revealing large hiatal hernia, gastric ulcer, gastric erosions, etc.
  17. Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
  18. Beck Depression Inventory (Short) Score ≥12 and/or uncontrolled depression after pre-enrollment psychological and medical assessment.
  19. Present or past history of psychosis, bipolar disease, or obsessive compulsive disorder after pre-enrollment history and medical /psychological assessment.
  20. Non-ambulatory or has significant impairment of mobility.
  21. Known hormonal or genetic cause for obesity with the exception of treated hypothyroidism.
  22. Participating in another clinical study.
  23. Is a relative of investigator or his/her staff, or is employed by investigator or institution involved in the study.
  24. Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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.
Active Comparator: Treatment group
The treatment of obese patients with the placement of g-Cath EZ suture anchors along with Diet and Exercise
Device: placement of g-Cath EZ suture anchors
Other Names:
  • g-Cath EZ™ Suture Anchor Delivery Catheter (USGI Medical)
Behavioral: Diet and Exercise
A structured diet and exercise plan
Sham Comparator: Sham Group
The treatment of obese patients with the sham procedure along with Diet and Exercise
Behavioral: Diet and Exercise
A structured diet and exercise plan
Procedure: Sham procedure

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
Measure Description
Time Frame
Total Body Weight Loss
Time Frame: Enrollment to 12 months
Evaluate the effectiveness of the g-Cath EZ™ Suture Anchor Delivery Catheter (USGI Medical, San Clemente, CA, USA) with diet and exercise as an early weight loss intervention for Class I obesity subjects with at least one non-severe obesity related co-morbid condition or Class II obesity subjects with or without a non-severe obesity related co-morbid condition compared to a sham procedure, diet and exercise group.
Enrollment to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life scores (IWQOL)
Time Frame: enrollment to 12 months
Assessment of changes
enrollment to 12 months
Comorbid status
Time Frame: Enrollment to 12 months
Assessment of changes from baseline at 12 months in hypertension, diabetes, and hyperlipidemia
Enrollment to 12 months
Eating Behavior changes
Time Frame: Enrollment to 12 months
assessment of changes from baseline at 12 months in eating behavior scores (TFEQ) and subjective changes in food capacity, hunger, and satiety in both study groups
Enrollment to 12 months

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: Tom Lavin, MD, Crescent City Surgical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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, 2013

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.
May 1, 2015

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.
August 1, 2016

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).
October 4, 2013

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.
October 8, 2013

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.
October 9, 2013

Study Record Updates

Last Update Posted (Actual)

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.
April 4, 2017

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.
March 31, 2017

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.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • G130163

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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