Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

ESSENTIAL Trial™ Sham Cross-over

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02279420
Recruitment Status : Completed
First Posted : October 31, 2014
Results First Posted : May 12, 2017
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
USGI Medical

Brief Summary:
This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.

Condition or disease Intervention/treatment Phase
Obesity Device: g-Cath EZ™ Suture Anchor Delivery Catheter Not Applicable

Detailed Description:

This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.

This supplemental study will consist of up to an 8 week screening period after each subject's unblinding visit, an enrollment (active treatment) day, and a 12-month follow-up period. All sham subjects in the Essential Trial (total quantity of one hundred eleven (111) subjects) are planned for enrollment, but the total quantity of sham subjects provided the active treatment will depend on the number of subjects who are compliant. The active treatment will be provided by the original investigator for that subject at the same investigational center (one of the original 11) used in the Essential trial. Collection of data will be accomplished by utilizing independent nutritionists/clinical research nurses to administer the diet/exercise plan and collect weight loss efficacy assessments. Efficacy assessments will also include changes in select co-morbidities, quality of life assessments, and changes in hunger and satiety, among others. Safety assessments include subject and investigator reported adverse events, physician follow-up assessments, and blood pressure measurements.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Supplemental Open Label Multicenter Sham Cross-over Clinical Trial Using an Endoscopic Suturing Device (g-Cath EZ™ Suture Anchor Delivery Catheter) For Primary Weight Loss Essential Study (IDE G130163) Crossover Study
Actual Study Start Date : January 5, 2015
Actual Primary Completion Date : August 31, 2016
Actual Study Completion Date : September 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Arm Intervention/treatment
Essential Study Sham Cross-over
Device: g-Cath EZ™ Suture Anchor Delivery Catheter This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.
Device: g-Cath EZ™ Suture Anchor Delivery Catheter
This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.




Primary Outcome Measures :
  1. Mean Percent Total Body Weight Loss [ Time Frame: 1 Year ]
    Percent total body weight loss calculated through 12 months post procedure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   23 Years to 61 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide written informed consent.
  2. Potential subject was sham participant in the Essential pivotal trial
  3. Potential subject agrees to be compliant with study and has a documented history of compliance in pivotal study.
  4. Subjects between the ages of 23-61 years.
  5. 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/baseline.
  6. 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 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 (See Section 14)
  7. Absence of current severe systemic disease (including, but not limited to: coronary artery disease, chronic obstructive pulmonary disease, congestive heart failure, cancer, and chronic renal disease)
  8. Agrees not to undergo any additional weight loss interventional procedures or liposuction for 12 months following study enrollment.
  9. Agrees not to utilize any prescription or over the counter weight loss medications OR those that can suppress appetite/induce weight loss for 12 months following study enrollment (including all stimulant medication).
  10. Be willing to cooperate with post-operative dietary recommendations and assessment tests.
  11. Residing 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 or procedure execution.
  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 drug therapy.
  4. Large hiatal hernia (>3 cm) by history or as determined by pre-enrollment endoscopy.
  5. Pancreatic insufficiency/disease.
  6. History of gastroparesis or symptoms that would be suggestive of gastroparesis.
  7. Pregnancy or plans of pregnancy in the next 12 months.
  8. Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 1 month of Visit 1. Intranasal/inhaled steroids are acceptable.
  9. History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis
  10. History or present use of insulin or insulin derivatives for treatment of diabetes
  11. Type II Diabetes Mellitus (as defined by HgbA1c >6.5%) for greater than 11 years at the time of enrollment
  12. If smoker, plans to quit smoking in the year after enrollment
  13. Portal hypertension and/or varices.
  14. Significant abnormality identified during Visit 2 (enrollment visit) with endoscopy revealing large hiatal hernia, gastric/duodenal ulcer, gastric erosions, gastric outlet obstruction or stenosis, etc.
  15. Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
  16. Present or past history of psychosis, bipolar disease, or obsessive compulsive disorder after pre-enrollment history and medical /psychological assessment
  17. Non-ambulatory or has significant impairment of mobility.
  18. Known hormonal or genetic cause for obesity including untreated hypothyroidism (TSH >5.0 U/ml).
  19. Participating in another clinical study except for Essential Study.
  20. Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279420


Locations
Layout table for location information
United States, Arizona
Shea Campus -Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
United States, Florida
University of Miami Hospital
Miami, Florida, United States, 33166
United States, Georgia
Hamilton Medical Center
Dalton, Georgia, United States, 30720
United States, Illinois
Northshore/Evanston Hospital
Evanston, Illinois, United States, 60201
United States, Louisiana
Crescent City Surgical
Metairie, Louisiana, United States, 70001
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
Fairview UMMC-University
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
WA University School of Medicine
St. Louis, Missouri, United States, 63110
United States, South Carolina
Lexington Medical Center
West Columbia, South Carolina, United States, 29169
United States, Tennessee
Baptist Memorial Hospital
Memphis, Tennessee, United States, 38120
Sponsors and Collaborators
USGI Medical
Investigators
Layout table for investigator information
Principal Investigator: Tom Lavin, MD Crescent City Surgical Centre

Layout table for additonal information
Responsible Party: USGI Medical
ClinicalTrials.gov Identifier: NCT02279420    
Other Study ID Numbers: TPR 50402
First Posted: October 31, 2014    Key Record Dates
Results First Posted: May 12, 2017
Last Update Posted: May 12, 2017
Last Verified: March 2017