ESSENTIAL Trial™ Sham Cross-over

NCT02279420 | Completed Results

• 1 other identifier: TPR 50402
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 11

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Mean Percent Total Body Weight Loss

  Percent total body weight loss calculated through 12 months post procedure

  1 Year

Study Arms (1)

Essential Study Sham Cross-over

OTHER

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

Interventions

g-Cath EZ™ Suture Anchor Delivery Catheter DEVICE

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.

Essential Study Sham Cross-over

Eligibility Criteria

• Age: 23 Years - 61 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Provide written informed consent.
• Potential subject was sham participant in the Essential pivotal trial
• Potential subject agrees to be compliant with study and has a documented history of compliance in pivotal study.
• Subjects between the ages of 23-61 years.
• 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.
• 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)
• 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)
• Agrees not to undergo any additional weight loss interventional procedures or liposuction for 12 months following study enrollment.
• 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).
• Be willing to cooperate with post-operative dietary recommendations and assessment tests.
• 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.

You may not qualify if:

• History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.
• Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments or procedure execution.
• 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.
• Large hiatal hernia (\>3 cm) by history or as determined by pre-enrollment endoscopy.
• Pancreatic insufficiency/disease.
• History of gastroparesis or symptoms that would be suggestive of gastroparesis.
• Pregnancy or plans of pregnancy in the next 12 months.
• Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 1 month of Visit 1. Intranasal/inhaled steroids are acceptable.
• History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis
• History or present use of insulin or insulin derivatives for treatment of diabetes
• Type II Diabetes Mellitus (as defined by HgbA1c \>6.5%) for greater than 11 years at the time of enrollment
• If smoker, plans to quit smoking in the year after enrollment
• Portal hypertension and/or varices.
• 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.
• Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.

Sponsors & Collaborators

• USGI Medical: lead

Study Sites (11)

Shea Campus -Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

Location

University of Miami Hospital

Miami, Florida, 33166, United States

Location

Hamilton Medical Center

Dalton, Georgia, 30720, United States

Location

Northshore/Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Crescent City Surgical

Metairie, Louisiana, 70001, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Fairview UMMC-University

Minneapolis, Minnesota, 55455, United States

Location

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

WA University School of Medicine

St Louis, Missouri, 63110, United States

Location

Lexington Medical Center

West Columbia, South Carolina, 29169, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Director of Clinical Research
• Organization: USGI Medical

samlung@usgimedical.com

9493693890

Study Officials

• Tom Lavin, MD

  Crescent City Surgical Centre

  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: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 31, 2014
• Study Start: January 5, 2015
• Primary Completion: August 31, 2016
• Study Completion: September 30, 2016
• Last Updated: May 12, 2017
• Results First Posted: May 12, 2017

Record last verified: 2017-03

Locations

US (11)