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Adjustable Balloons for Weight Loss: A Higher Yield of Responders Compared With Non-Adjustable Balloons

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ClinicalTrials.gov Identifier: NCT03473938
Recruitment Status : Completed
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Collaborators:
Clínica Opcíon Médica Barcelona
Optimal Clinic Tel Aviv
Medical Faculty, University of Ostrava
Information provided by (Responsible Party):
University Hospital Ostrava

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.

Condition or disease Intervention/treatment
Obesity Device: 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.


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Study Type : Observational
Actual Enrollment : 227 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Adjustable Balloons for Weight Loss: A Higher Yield of Responders Compared With Non-Adjustable Balloons
Actual Study Start Date : May 1, 2015
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : January 31, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Spatz3 AIGB
Patients with implanted Spatz3 AIGB balloon.
Device: Spatz3 AIGB
Implantation of Spatz3 AIGB balloon.




Primary Outcome Measures :
  1. Weight loss [ Time Frame: 8 months ]
    The achieved weight loss was recorded for the patients in the study.


Secondary Outcome Measures :
  1. Balloon intolerance [ Time Frame: 8 months ]
    Intolerance of the intragastric balloon was recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473938


Locations
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Czechia
University of Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 701 03
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 708 52
Israel
Optimal Clinic
Tel Aviv, Israel
Spain
Clínica Opcíon Médica
Barcelona, Spain
Sponsors and Collaborators
University Hospital Ostrava
Clínica Opcíon Médica Barcelona
Optimal Clinic Tel Aviv
Medical Faculty, University of Ostrava
Investigators
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Study Director: Evžen Machytka, MD,PhD University Hospital Ostrava

Publications:

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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT03473938     History of Changes
Other Study ID Numbers: FNO-IK-Intragastric-Balloon
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The authors have no plan make individual participant data available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Ostrava:
Obesity
Weight loss
Intragastric balloons
Adjustable gastric balloon
Weight loss plateau
Intolerance

Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms