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Treatment of ObesityNCT03721731

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

An observational study of Treatment of Obesity, run by USGI Medical at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multi-center, prospective study evaluating a treatment for obesity. Read more about this study

Who is it for?
Ages 22 to 60 years
Conditions the study is for
Treatment of Obesity
What is being tested?
Obesity treatment with a Plication device
Type of treatment
Medical device
How many people
39 participants
Where
2 sitesSpain
Study dates
18 Sep 2018to 21 Feb 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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.
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  • 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).
  • Agrees not to undergo any additional weight loss interventional procedures or liposuction for 12 months following study enrollment.
  • Have not taken any prescription or over the counter weight loss medications OR those that can suppress appetite/induce weight loss for at least 6 months and agrees not to utilize for 12 months following study enrollment (including all stimulant medication).
  • Subjects must be willing to possibly forego any future weight loss procedures (i.e. Vertical Sleeve Gastrectomy) given the unknown long-term effects.

Who cannot join

  • 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).
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  • 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.
  • Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
  • Present or past history of psychosis, bipolar disease, or obsessive-compulsive disorder after pre-enrollment history and medical /psychological assessment.
  • Beck Depression Inventory (Short) Score ≥ 12 and/or uncontrolled depression after pre-enrollment psychological and medical assessment. 1
  • Non-ambulatory or has significant impairment of mobility (i.e. cannot ambulate for 30 minutes).
  • Known hormonal or genetic cause for obesity including untreated hypothyroidism (TSH >5.0 U/ml).
  • Participating in another clinical study.
  • Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.
  • Physician's assessment that the subject is not an appropriate candidate. If significant findings for depression and/or suicidal ideation are identified, the psychologist(s) assigned to the study will be contacted and arrangement will be made for immediate intervention according to the Institution's standard procedure.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Centro Medico Teknon

    Barcelona, 08022

  • Madrid Sanchinarro University Hospital

    Madrid, 28050

Other trials in Spain

About this study

Official title: A Post-Market Surveillance Study Examining the Safety & Effectiveness of Using the g-Cath EZ Delivery Catheter With Snowshoe Suture Anchors and Associated Devices (g-Prox EZ, g-Lix and Transport) for the Treatment of Obesity

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

Read the detailed description

This is a multi-center, prospective study evaluating a treatment for obesity using the g-Cath EZ and associated devices. The intent is to evaluate the safety and efficacy of a modified Snowshoe suture anchor placement pattern called Pose 2 (suture anchors placed in the mid + distal body of the stomach, with none placed in the fundus) along with a moderate intensity diet and exercise program. The g-Cath EZ and the associated devices (the g-Prox EZ, g-Lix \& Transport) are known collectively as the Incisionless Operating Platform (IOP). Efficacy of the treatment will be evaluated based on changes in weight loss over 12 months, \& adverse events will be recorded throughout the duration of the study.

Being tested
Obesity treatment with a Plication device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Obesity treatment with a Plication deviceDevice

    Plicating the stomach to treat obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean % TBWL at 12 months

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

    Measured: 12 months

  2. 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

    Measured: 12 months

  3. Incidence of Procedure/device related Adverse Events thru 12 months

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

    Measured: 12 months

Secondary outcomes (1)

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

    Gather Info on correlation of gastric emptying testing with weight loss outcome

    Measured: 2 & 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2018
  2. Study start18 Sep 2018
  3. Primary completion21 Feb 2020
  4. Study completion21 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03721731
Sponsor's protocol ID
50518 TPR
Status last verified
Oct 2018
First submitted
22 Oct 2018
Last updated
4 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 35533995

Questions about this trial

What is this clinical trial studying?

An observational study of Treatment of Obesity, run by USGI Medical at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean % TBWL at 12 months (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03721731, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.

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