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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03473938
• Other study ID #: FNO-IK-Intragastric-Balloon
• Status: Completed
• First received: March 14, 2018
• Last updated: March 14, 2018
• Start date: May 1, 2015
• Est. completion date: January 31, 2016

Study information

• Verified date: March 2018
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: January 31, 2016
• Est. primary completion date: December 31, 2015
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Device:
• Spatz3 AIGB
Implantation of Spatz3 AIGB balloon.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region
Czechia	University of Ostrava	Ostrava	Moravian-Silesian Region
Israel	Optimal Clinic	Tel Aviv
Spain	Clínica Opcíon Médica	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Ostrava	Clínica Opcíon Médica Barcelona, Medical Faculty, University of Ostrava, Optimal Clinic Tel Aviv

Countries where clinical trial is conducted

Czechia,  Israel,  Spain, 

References & Publications (23)

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Bonazzi P, Petrelli MD, Lorenzini I, Peruzzi E, Nicolai A, Galeazzi R. Gastric emptying and intragastric balloon in obese patients. Eur Rev Med Pharmacol Sci. 2005 Sep-Oct;9(5 Suppl 1):15-21. — View Citation

Brooks J, Srivastava ED, Mathus-Vliegen EM. One-year adjustable intragastric balloons: results in 73 consecutive patients in the U.K. Obes Surg. 2014 May;24(5):813-9. doi: 10.1007/s11695-014-1176-3. — View Citation

Busetto L, Segato G, De Luca M, Bortolozzi E, MacCari T, Magon A, Inelmen EM, Favretti F, Enzi G. Preoperative weight loss by intragastric balloon in super-obese patients treated with laparoscopic gastric banding: a case-control study. Obes Surg. 2004 May;14(5):671-6. — View Citation

Courcoulas A, Abu Dayyeh BK, Eaton L, Robinson J, Woodman G, Fusco M, Shayani V, Billy H, Pambianco D, Gostout C. Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial. Int J Obes (Lond). 2017 Mar;41(3):427-433. doi: 10.1038/ijo.2016.229. Epub 2016 Dec 23. — View Citation

Dastis NS, François E, Deviere J, Hittelet A, Ilah Mehdi A, Barea M, Dumonceau JM. Intragastric balloon for weight loss: results in 100 individuals followed for at least 2.5 years. Endoscopy. 2009 Jul;41(7):575-80. doi: 10.1055/s-0029-1214826. Epub 2009 Jul 8. — View Citation

Doldi SB, Micheletto G, Di Prisco F, Zappa MA, Lattuada E, Reitano M. Intragastric balloon in obese patients. Obes Surg. 2000 Dec;10(6):578-81. — View Citation

Doldi SB, Micheletto G, Perrini MN, Librenti MC, Rella S. Treatment of morbid obesity with intragastric balloon in association with diet. Obes Surg. 2002 Aug;12(4):583-7. — View Citation

Doldi SB, Micheletto G, Perrini MN, Rapetti R. Intragastric balloon: another option for treatment of obesity and morbid obesity. Hepatogastroenterology. 2004 Jan-Feb;51(55):294-7. Retraction in: Hepatogastroenterology. 2012 Nov-Dec;59(120):2683. — View Citation

Evans JD, Scott MH. Intragastric balloon in the treatment of patients with morbid obesity. Br J Surg. 2001 Sep;88(9):1245-8. — View Citation

Genco A, Cipriano M, Bacci V, Cuzzolaro M, Materia A, Raparelli L, Docimo C, Lorenzo M, Basso N. BioEnterics Intragastric Balloon (BIB): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients. Int J Obes (Lond). 2006 Jan;30(1):129-33. — View Citation

Gómez V, Woodman G, Abu Dayyeh BK. Delayed gastric emptying as a proposed mechanism of action during intragastric balloon therapy: Results of a prospective study. Obesity (Silver Spring). 2016 Sep;24(9):1849-53. doi: 10.1002/oby.21555. Epub 2016 Jul 28. — View Citation

Herve J, Wahlen CH, Schaeken A, Dallemagne B, Dewandre JM, Markiewicz S, Monami B, Weerts J, Jehaes C. What becomes of patients one year after the intragastric balloon has been removed? Obes Surg. 2005 Jun-Jul;15(6):864-70. — View Citation

Imaz I, Martínez-Cervell C, García-Alvarez EE, Sendra-Gutiérrez JM, González-Enríquez J. Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis. Obes Surg. 2008 Jul;18(7):841-6. doi: 10.1007/s11695-007-9331-8. Epub 2008 May 6. Review. — View Citation

Machytka E, Klvana P, Kornbluth A, Peikin S, Mathus-Vliegen LE, Gostout C, Lopez-Nava G, Shikora S, Brooks J. Adjustable intragastric balloons: a 12-month pilot trial in endoscopic weight loss management. Obes Surg. 2011 Oct;21(10):1499-507. doi: 10.1007/s11695-011-0424-z. — View Citation

Mathus-Vliegen EM, Tytgat GN. Intragastric balloon for treatment-resistant obesity: safety, tolerance, and efficacy of 1-year balloon treatment followed by a 1-year balloon-free follow-up. Gastrointest Endosc. 2005 Jan;61(1):19-27. — View Citation

Mathus-Vliegen EM. Intragastric balloon treatment for obesity: what does it really offer? Dig Dis. 2008;26(1):40-4. doi: 10.1159/000109385. Epub 2008 Feb 15. Review. — View Citation

Melissas J, Mouzas J, Filis D, Daskalakis M, Matrella E, Papadakis JA, Sevrisarianos N, Charalambides D. The intragastric balloon - smoothing the path to bariatric surgery. Obes Surg. 2006 Jul;16(7):897-902. — View Citation

Mion F, Napoléon B, Roman S, Malvoisin E, Trepo F, Pujol B, Lefort C, Bory RM. Effects of intragastric balloon on gastric emptying and plasma ghrelin levels in non-morbid obese patients. Obes Surg. 2005 Apr;15(4):510-6. — View Citation

Roman S, Napoléon B, Mion F, Bory RM, Guyot P, D'Orazio H, Benchetrit S. Intragastric balloon for "non-morbid" obesity: a retrospective evaluation of tolerance and efficacy. Obes Surg. 2004 Apr;14(4):539-44. — View Citation

Sallet JA, Marchesini JB, Paiva DS, Komoto K, Pizani CE, Ribeiro ML, Miguel P, Ferraz AM, Sallet PC. Brazilian multicenter study of the intragastric balloon. Obes Surg. 2004 Aug;14(7):991-8. — View Citation

Totté E, Hendrickx L, Pauwels M, Van Hee R. Weight reduction by means of intragastric device: experience with the bioenterics intragastric balloon. Obes Surg. 2001 Aug;11(4):519-23. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	The achieved weight loss was recorded for the patients in the study.	8 months
Secondary	Balloon intolerance	Intolerance of the intragastric balloon was recorded.	8 months