Obesity Clinical Trial
Official title:
Adjustable Balloons for Weight Loss: A Higher Yield of Responders Compared With Non-Adjustable Balloons
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |