None listed
Conditions
Brief summary
The main purpose of the study is to compare two different instruments that are used to assess and treat conditions of the small bowel.
Interventions
Adult males and females referred for Balloon Enteroscopy for investigation or treatment of small bowel conditions will be randomised either to Single Balloon enteroscopy (SBE) or Double Balloon Enteroscopy (DBE).
Single Balloon technology is designed to allow examination of the small bowel utilising a single balloon that maybe inflated or deflated to aid propulsion into the bowel. This is unique as the current alternative of double balloon enteroscopy requires two balloons that need to be in
Adult males and females referred for Balloon Enteroscopy for investigation or treatment of small bowel conditions will be randomised either to Single Balloon enteroscopy (SBE) or Double Balloon Enteroscopy (DBE). Single Balloon technology is designed to allow examination of the small bowel utilising a single balloon that maybe inflated or deflated to aid propulsion into the bowel. This is unique as the current alternative of double balloon enteroscopy requires two balloons that need to be independently controlled. Utilising a single balloon limits the complexity of the procedure. Study duration will be 2 years and patients will be recruited over 18months. Each patient will undergo one procedure.
Sponsors
St Vincent's Hospital Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult >18 years Clinically accepted indication for Balloon enteroscopy. Willingness to participate
Exclusion criteria
Any contraindication to Balloon Enteroscopy.
Outcome results
None listed