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Completed

NCT Number: NCT01910688

Use of Radiofrequency Ablation for RGB Salvage

The present study will assess the feasibility of using endoscopic radiofrequency ablation (RFA) to treat the gastric pouch and stoma with the intent to cause tissue contraction and decreased compliance after a failed Roux-en-Y gastric bypass.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

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About this study

Obesity is a leading cause of preventable death in the United States, with approximately 300,000 related deaths per year. The most commonly performed bariatric surgical interventions are Roux-en Y gastric bypass (RGB) and laparoscopic adjustable gastric band placement. Despite the overall initial success of RGB to induce significant EBWL in the majority of patients, significant weight regain occurs in about 25% of patients at 2+ years following surgery. Given the preliminary success of endoscopic, non-surgical salvage interventions for the failed (uncomplicated) RGB patient, the present study will assess the feasibility of using endoscopic radiofrequency ablation (RFA) to treat the gastric pouch and stoma with the intent to cause tissue contraction and decreased compliance. A reduction of size and compliance may, as others have reported, result in re-establish weight loss and achieve an acceptable EBWL with minimal patient morbidity.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of RGB surgery at least 1 year prior to enrollment
  • Achievement of > 40% EBWL after RGB
  • Weight regain of > 25% of the lost weight at the time of enrollment. For example, if excess body weight was 50 kg prior to RGB, patient must have lost at least 20 kg after RGB, then regained at least 5 kg to be eligible for the present study
  • Age 18-70 inclusive
  • Subject is able to tolerate endoscopy and sedation
  • Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form (ICF)

Exclusion criteria

  • History of any bariatric surgery other than RGB, including lap band
  • History or presence of a gastrogastric fistula or gastric pouch / jejunal ulceration
  • Gastrojejunostomy > 4 cm in diameter (size estimated at time of endoscopy)
  • Perceived inability of the patient by the Investigator to comply with a post-treatment diet or medication regimen
  • History of alcohol, tobacco and/or controlled substance dependency that would impair the patient from complying with protocol requirements
  • Pregnancy
  • Subject is unable to provide informed consent for this study

Treatment and study plan

RFA treatment

Device

If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis.

Other names: HALO60, HALO90, HALO90 Ultra

Primary outcomes

  1. Excess Body Weight Loss After RFA Treatment

    Time frame: 12 months

    EBWL 12 months after enrollment

Secondary outcomes

  1. Technical Feasibility: Percentage of Participants Who Completed RFA Treatment

    Time frame: Day 0, month 4, month 8

    Technical feasibility of applying RFA to gastric pouch and gastrojejunostomy. This will be assessed by asking the physician for feedback on ease of use, ease of intubation and extubation,did the physician achieve tissue contact in targeted areas, was targeted area successfully ablated.

  2. Patient Tolerability

    Time frame: 12 months

    Patient tolerability of the procedure. Patient tolerability will be measured by assessing adverse events related to the device or procedure. The Investigator will assess each adverse event with respect to severity and relationship to the study device.

  3. Adverse Events

    Time frame: 12 months

    Adverse event profile: Relationship to study device : Definite, Probable, Possible

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

Use of Endoscopically Delivered Radiofrequency Ablation for the Treatment of Ptients Who Have Undergone Roux-en-Y Gastric Bypass and Have Failed to Achieve/ Maintain Satisfactory Excess Body Weight Loss

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 30, 2013
Registry last updated
Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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