Individual research recommendation details

Recommendation ID

IPG684/1

Question

Evidence on the safety of the swallowable gastric balloon capsule for weight loss shows infrequent but potentially serious adverse events:

• For people who need to lose weight in the short term for medical reasons, the evidence of efficacy is adequate to support the use of this procedure provided that special arrangements are in place for clinical governance, consent and audit. Find out what special arrangements mean on the NICE interventional procedures guidance page.

• For people who are aiming for long-term weight loss, the evidence on efficacy is inadequate in quantity and quality, so the procedure should only be used in the context of research. Find out what only in research means on the NICE interventional procedures guidance page.

Any explanatory notes
(if applicable)

1.2Clinicians wishing to use a swallowable gastric balloon capsule for weight loss should:

• Inform the clinical governance leads in their healthcare organisation.

• Give patients (and their families and carers as appropriate) clear written information to support shared decision making, including NICE's information for the public.

• Ensure that patients (and their families and carers as appropriate) understand the procedure's safety and efficacy, and any uncertainties about these.

• Audit and review clinical outcomes of all patients having the procedure. The main efficacy and safety outcomes identified in this guidance can be entered into NICE's interventional procedure outcomes audit tool (for use at local discretion).

• Discuss the outcomes of the procedure during their annual appraisal to reflect, learn and improve.

1.3Further research could be in the form of randomised controlled trials comparing the procedure with current standard therapies, or an observational cohort study, including using registry data. Studies should include details of patient selection such as body mass index and other treatments such as diet and lifestyle changes. They should also report:

• short- and long-term weight loss

• quality of life

• metabolic parameters

• the need for later surgery.

Source guidance details

Comes from guidance

Swallowable gastric balloon capsule for weight loss

Number

IPG684

Date issued

November 2020

Other details