Weight Reduction by Means of Intragastric Device: Experience with the Bioenterics Intragastric Balloon

Totté, E.; Hendrickx, L.; Pauwels, Mathieu; Hee, R. Van

doi:10.1381/096089201321209459

Cited by 105 publications

(88 citation statements)

References 6 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Extensive clinical experience has shown that the complication rate is very low. 5,6,8,9,[15][16][17] In the present study, BIB placement was safe and feasible. In all cases it was positioned after sedation only.…”

Section: -15supporting

confidence: 47%

BioEnterics® Intragastric Balloon (BIB®): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients

et al. 2005

View full text Add to dashboard Cite

Background: The BioEnterics s Intragastric Balloon (BIB s ) System in association with restricted diet has been used for the shortterm treatment of morbid obesity. Aim of this study was to evaluate the real, short term, efficacy of the BIB for weight reduction in morbidly obese patients by using a prospective, double-blind, randomised, sham-controlled, crossover study. Methods: Patients were recruited from January 2003 to December 2003. After selection, they were randomly allocated into two groups: BIB followed by sham procedure after 3 months (Group A), and sham procedure followed by BIB after 3 months (Group B). All endoscopic procedures were performed under unconscious intravenous sedation. The BioEnterics Intragastric Balloon (Inamed Health; Santa Barbara, CA, USA) was filled by using saline (500 ml) and methylene blue (10 ml). Patients were discharged with omeprazole therapy and diet (1000 kcal). Patients were followed up weekly by a physician blinded to randomisation. In both groups mortality, complications, BMI, BMI reduction and %EWL were considered. Data were expressed as mean7s.d., except as otherwise indicated. Statistical analysis was performed by means of Student's t-test, Fisher's exact test or w 2 with Yates correction; Po0.05 was considered significant. Results: A total of 32 patients were selected and entered the study (8M/24F; mean age: 36.275.6 years, range 25-50 years; mean BMI 43.771.5 kg/m 2 , range 40-45 kg/m 2 ; mean %EW: 43.1713.1, range: 35-65). All patients completed the study. Mortality was absent. Complications related to endoscopy, balloon placement and removal were absent. Mean time of BIB positioning was 1572 min, range 10-20 min. After the first 3 months of the study, in Group A patients the mean BMI significantly (Po0.001) lowered from 43.571.1 to 38.072.6 kg/m 2 , while in Group B patients the decrease was not significant (from 43.671.8 to 43.172.8 kg/m 2 ). The mean %EWL was significantly higher in Group A than in Group B (34.074.8 vs 2.171%; Po0.001). After crossover, at the end of the following 3 months, the BMI lowered from 38.072.6 to 37.173.4 kg/m 2 and from 43.172.8 to 38.873.1 kg/m 2 in Groups A and B, respectively. Conclusions: The results of this study show that treatment of obese patients with BioEnterics Intragastric Balloon is a safe and effective procedure. In association with appropriate diet it is significantly effective in weight reduction when compared to sham procedure plus diet. The BIB s procedure can play a role in weight reduction in morbidly obese patients or in the preoperative treatment of bariatric patients.

show abstract

Section: -15supporting

confidence: 47%

BioEnterics® Intragastric Balloon (BIB®): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients

et al. 2005

View full text Add to dashboard Cite

show abstract

“…Previously published results revealed an average weight loss of 12-15 kg over 6 months with an excellent safety profile [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16] . The Spatz Adjustable balloon was introduced in 2010 as the first IGB approved for 1 year implantation while featuring an adjustability function that afforded balloon volume changes as needed.…”

Section: Introductionmentioning

confidence: 99%

“…It was approved in May 2010 in all 27 countries of the European Union for patients with BMI > 27 that failed previous attempts at weight loss (certificate number 10 0384 QS/NB). The adjustability function was developed to address the issues related to other standard 6 months IGBs; 1) reduced efficacy after 2 to 3 months from implantation 3,16 , and 2) significant nausea, vomiting, and discomfort in the early implantation period, necessitating balloon extraction in 4-7% of patients 1,2 17,18 . In 2012, the Spatz3 adjustable balloon was approved for 1 year implantation with the same features as the original Spatz balloon, but with a softer and smaller profile catheter.…”

Section: Introductionmentioning

confidence: 99%

One year adjustable intragastric balloon: safety and efficacy of the Spatz3 adjustable balloons

Machytka

Brooks²,

Bužga

et al. 2014

F1000Res

View full text Add to dashboard Cite

Discuss this article AbstractThe Spatz3 Adjustable balloon system is approved for 1 year Background: implantation and allows multiple changes in the balloon volume during the course of implantation. Other intragastric balloons are currently approved for 6 months and their balloon volumes cannot be adjusted after implantation.To determine the efficacy and safety of the Spatz3 adjustable balloon Aim: system.Seventy seven consecutive patients (66 females and 11 males) in Methods: two medical centers were implanted with the Spatz3 adjustable balloon device and were followed prospectively. The patients' mean BMI was 37.2; the mean weight was 108.7 kg; the mean age was 41 (16-68); the mean balloon volume was 469 ml (450-500 ml). Adjustments were made for intolerance or weight loss plateau.The mean weight loss at 1 year was 17.2 kg with 15.9 % weight loss Results: and 42.9 % Excess Weight Loss (%EWL). Eighteen patients underwent balloon volume adjustments: three downward adjustments of 100 -150 cc which alleviated early intolerance; 15 upward adjustments (mean 320 ml; range 200-500) at a mean 4.1 months (range 2-5 months) yielded additional mean wt loss of 8.2 kg (range 0-25 kg) after the adjustment. Three balloons were removed before the 1 year completion date due to intolerance and three others were removed for other reasons (pregnancy, gall bladder surgery, and alcoholism). There was one episode of gastric ulceration which required endoscopic therapy and balloon removal. There were no deflations or perforations.The Spatz3 adjustable balloon is a safe and effective treatment Conclusions: for weight loss. The adjustability function can yield greater weight loss for those who show weight loss plateau and can mitigate intolerance.

show abstract

“…Furthermore, European trials found patients lose 25-40% of their excess weight after six months [9]. Other studies also find that gastric balloons do cause significant weight loss [10,11], and the amount of weight loss is consistent over studies [1].…”

Section: How Effective Are Gastric Balloons For Weight Loss?mentioning

confidence: 91%

The Effect of Gastric Balloons on Weight Loss

Alenazi¹

2016

AOWMC

View full text Add to dashboard Cite

Submit Manuscript | http://medcraveonline.com volume and therefore increases satiety [5]. This literature review will examine the effect of gastric balloons on weight loss. First the review will examine the effectiveness of gastric balloons for weight loss, and then the review will consider hoe permanent the weight loss is. Then the review will examine who is suitable for gastric balloons, and finally his review will consider the method by which gastric balloons cause weight loss.

show abstract

Weight Reduction by Means of Intragastric Device: Experience with the Bioenterics Intragastric Balloon

Abstract: BIB as a means of weight reduction in the obese patient led to a 50.8% loss of excess weight after 6 months. Although severe morbidity can occur, the BIB provides a means for short-term weight reduction in conjunction with dietary measures.

Cited by 105 publications

References 6 publications

BioEnterics® Intragastric Balloon (BIB®): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients

BioEnterics® Intragastric Balloon (BIB®): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients

One year adjustable intragastric balloon: safety and efficacy of the Spatz3 adjustable balloons

The Effect of Gastric Balloons on Weight Loss

Contact Info

Product

Resources

About