A Post-Market Surveillance Study of Using the g-Cath EZ for Treating Obesity

NCT03721731 | Completed FDA Device

• 1 other identifier: 50518 TPR
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multi-center, prospective study evaluating a treatment for obesity.

Conditions

Treatment of Obesity

Outcome Measures

Primary Outcomes (3)

• Mean % TBWL at 12 months

  What is the Mean % TBWL for all Subjects at 12 months

  12 months

• Percentage of subjects with greater than/equal to 5% TBWL at 12 months

  What % of subjects who have greater than/equal to 5% TBWL at 12 months

  12 months

• Incidence of Procedure/device related Adverse Events thru 12 months

  Overall incidence of procedure/device related adverse events thru 12 months

  12 months

Secondary Outcomes (1)

• Change from baseline in gastric emptying test results at 2 and 6 months

  2 & 6 months

Interventions

Obesity treatment with a Plication device DEVICE

Plicating the stomach to treat obesity

Eligibility Criteria

• Age: 22 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Current patients of Roman Turro, MD at Centro Medico Teknon in Barcelona, Spain and Gontrand Lopez-Nava, MD at Madrid Sanchinarro University Hospital in Madrid, Spain

You may qualify if:

• Provision of signed and dated informed consent form
• Subject agrees to be compliant with study requirements and adhere to post-operative dietary \& exercise recommendations for the duration of the study.
• Subjects between the ages of 22-60 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 ≥ 35 and \< 40 with one obesity related co-morbid condition (defined by 1991 NIH Guidelines with document referenced by FDA (Appropriateness Criteria for Bariatric Surgery: Beyond the NIH Guidelines)).
• Pre-diabetes - Fasting plasma glucose test \>100 mg/dl but ≤125 or oral glucose tolerance test ≥140 mg/dl but \<200.
• Diabetes - Individuals taking insulin and/or oral hypoglycemic medications or have a fasting glucose \>126 mg/dl.
• Hypertension - SBP\>140 or DBP\>90 or the use of an antihypertensive medication
• Dyslipidemia - Triglycerides \> 250 mg/dl or cholesterol \> 220 mg/dl or HDL \< 35 mg/dl or LDL \> 200 or use of lipid lowering medications.
• Sleep Apnea - A formal sleep study test consistent with this diagnosis; Epworth sleepiness scale ≥ 6; Polysomnography with respiratory disturbance index ≥ 10 hyponeic and/or apneic episodes per hour of sleep.
• Venous Stasis Disease - Presence or history of pretibial venous stasis ulcers.
• Chronic Joint Disease - Deterioration of joint cartilage and the formation of new bone (bone spurs) at the margins of the joints.
• Quality of Life - Impaired quality of life is defined as poor quality of life as measured by a formal and previously validated quality of life (QOL) questionnaire (e.g. SF-12)
• Gastroesophageal Reflux - Heartburn regurgitation or pain with swallowing and chest pain. Symptoms relieved by antacid medications.
• 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).

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 endoluminal instruments or procedure execution.
• Moderate 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 or generalized dysmotility (e.g. esophago-gastric motility issues and lower esophageal sphincter abnormalities).
• 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.
• Active gastric erosion, lesion, or gastric/duodenal ulcer.
• History of or current platelet or coagulation dysfunction.
• 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.

Sponsors & Collaborators

• USGI Medical: lead
• Centro Medico Teknon: collaborator
• Hospital Universitario Madrid Sanchinarro: collaborator

Study Sites (2)

Centro Medico Teknon

Barcelona, 08022, Spain

Location

Madrid Sanchinarro University Hospital

Madrid, 28050, Spain

Location

Related Publications (1)

• Lopez Nava G, Arau RT, Asokkumar R, Maselli DB, Rapaka B, Matar R, Bautista I, Espinos Perez JC, Bilbao AM, Jaruvongvanich V, Vargas EJ, Storm AC, Neto MG, Abu Dayyeh BK. Prospective Multicenter Study of the Primary Obesity Surgery Endoluminal (POSE 2.0) Procedure for Treatment of Obesity. Clin Gastroenterol Hepatol. 2023 Jan;21(1):81-89.e4. doi: 10.1016/j.cgh.2022.04.019. Epub 2022 May 6.

  PMID: 35533995 DERIVED

Study Officials

• Roman Turro, MD

  Centro Medico Teknon

  PRINCIPAL INVESTIGATOR

• Gontrand Lopez-Nava, MD

  Madrid Sanchinarro University Hospital

  PRINCIPAL INVESTIGATOR

• Barham Abu Dayyeh, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 26, 2018
• Study Start: September 18, 2018
• Primary Completion: February 21, 2020
• Study Completion: February 21, 2020
• Last Updated: November 4, 2020

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)