Clinical trial NCT03473938: Adjustable Balloons for Weight Loss: A Higher Yield of Responders Compared With Non-Adjustable Balloons
Official title: Adjustable Balloons for Weight Loss: A Higher Yield of Responders Compared With Non-Adjustable Balloons
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Obesity
Weight loss
Intragastric balloons
Adjustable gastric balloon
Weight loss plateau
Intolerance
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
Collaborators: name: Clínica Opcíon Médica Barcelona
name: Optimal Clinic Tel Aviv
name: University of Ostrava
First posted: 2018-03-22
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a temporary weight loss treatment, with body mass index (BMI) in the range of bariatric surgery (\>35) who refuse surgery or are at high risk for surgery or a temporary weight loss treatment without indications for surgery (BMI \> 29).

Brief summary: Intragastric balloon degree of efficacy and duration of effect can be variable and unpredictable. The Spatz Adjustable intragastric balloon (AIGB) was developed to extend implantation to 1 year, decrease balloon volume for intolerance and increase volume for diminishing effect. The aim of the study was to determine the utility/efficacy and responder rate with the Spatz3 AIGB.

Detailed description: The results of the Spatz adjustable balloon system have been reported in four studies with weight losses of 24.4 kg (48.8% excess weight loss - EWL), 21.6 kg (45.7% EWL),17.2 kg (42.9% EWL) and 16.3 kg (67.4% EWL), respectively. The responder rate (\>25% EWL) was 88.5% in one recent study.

The authors report and analyze the results of 227 Spatz3 patients retrospectively reviewed in 3 centers- some adjusted and some not adjusted during the course of their 1-year implantation - to determine if the adjustment option can improve overall results and diminish the non-responder rate.

The Spatz3 Adjustable intragastric balloon (IGB) (Spatz FGIA, Inc. New York, USA) was implanted at the following centers between May and December 2015: University Hospital, Ostrava, Czech Republic, Clinica Opcion Medica, Barcelona, Spain, and Optimal Clinic, Tel Aviv, Israel. Patients were selected according to the well-established criteria for intragastric balloon implantation, consistent with NIH and CE Mark guidelines, and were independently evaluated by members of the staff: gastroenterologists, dieticians, and psychologists. Indications for Spatz3 Adjustable IGB implantation included one of the following: (1) temporary weight loss treatment in a patient with body mass index (BMI) in the range of bariatric surgery (\>35) who refuse surgery or are at high risk for surgery, (2) temporary weight loss treatment for a patient without indications for surgery (BMI\>29). All patients underwent upper gastrointestinal endoscopy using conscious sedation with or without an anesthetist using one or more of the following medications - Propofol, Midazolam, and Fentanyl.

Balloons were inflated with a mean 464ml (400-500ml) of normal saline with the addition of 2-3 ml of a 1% solution of Methylene Blue (not used in the Czech Republic center). Patients were recovered for 45 minutes and discharged the same day on a once-daily PPI, anti-nausea medications (Aprepitant 125 mg day 1; 80 mg days 2 and 3), ondansetron (8 mg Q6H X 3 days), anti-spasmodic (papaverine 80 mg tid prn), and dietary instructions. After the fifth post-procedure day, a progressive full liquid to soft to solid 1,200-1,400 kcal diet was started. Monthly follow up with dietician and/or doctor (gastroenterologist or endocrinologist) was offered to all patients after implantation. Cognitive behavioral therapy by licensed psychologists was offered in 2 of the 3 centers (206/227 patients) with 6-10 sessions after implantation. Patients who were intolerant to the balloon could be adjusted downward by 100-150 ml. Patients with one or more of the following were offered upward adjustments of the balloon volume (200-400 ml at the discretion of the endoscopist): weight loss plateau; lack of balloon effect; ability to overeat without resultant symptoms (any of the following: nausea, vomiting, bloating, eructation, abdominal pain, acid reflux symptoms). Preparation for an adjustment or extraction procedure required the following diet: 3 days prior- no meat or vegetables; 2 days prior- full liquids; 1 day prior- clear liquids and NPO after midnight. After 12 months of placement, the balloon was deflated by aspiration via standard balloon needle or deflation utilizing the valve, and extraction was completed using a grasping forceps or a polypectomy snare - all under conscious sedation.

Eligibility criteria: Inclusion Criteria:

* temporary weight loss treatment in a patient with body mass index (BMI) in the range of bariatric surgery (\>35) who refuse surgery or are at high risk for surgery
* temporary weight loss treatment for a patient without indications for surgery (BMI \> 29)

Exclusion Criteria:

- none

Primary outcomes:
measure: Weight loss
timeFrame: 8 months
Secondary outcomes:
measure: Balloon intolerance
timeFrame: 8 months
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University of Ostrava
state: Moravian-Silesian Region
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
city: Tel Aviv
country: Israel
facility: Optimal Clinic
city: Barcelona
country: Spain
facility: Clínica Opcíon Médica
Study officials:
affiliation: University Hospital Ostrava
name: Evžen Machytka, MD,PhD
role: STUDY_DIRECTOR
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