Testing of 8mm A-Tube in AspireAssist™ Aspiration Therapy System

Testing of 8mm A-Tube in AspireAssist™ Aspiration Therapy System: a single center / single- arm study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN30159630

Enrollment

Registered

2014-05-22

Start date

2014-05-15

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of Obesity Nutritional, Metabolic, Endocrine Obesity

Interventions

This AspireAssist Aspiration Therapy study is an interventional study without a control. The intervention requires percutaneous endoscopic replacement of the 6mm A-Tube which is similar to a standard

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient should currently be a user of the AspireAssist device and have used it for at least six (6) months

Exclusion criteria

Exclusion criteria: 1. Active infection at the A-Tube 2. Recent (1 month) myocardial infarction 3. The patient is for some reason not considered likely to follow the instructions in the study with respect to diary completion

Design outcomes

Primary

Measure	Time frame
1. The dependent variable: aspiration time, number of blockages of food at the start of the study and at 7 weeks 2. Independent variables: 6mm A-Tube or 8mm A-Tube, chewing time	—

Secondary

Measure	Time frame
1. The dependent variable: complications (yes/no) 2. Independent variables: 6mm A-Tube or 8mm A-Tube	—

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026