ORBIT - I
Research type
Research Study
Full title
Outcome Research in Bowel Irrigation Techniques: A novel self-retaining catheter compared with a conventional balloon catheter for the treatment of chronic constipation and/or faecal incontinence, a real-world randomised explorative investigation.
IRAS ID
363586
Contact name
Thomas Dudding
Contact email
Sponsor organisation
Qufora A/S
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 28 days
Research summary
The ORBIT-I clinical investigation is a post-market, exploratory, randomised, parallel, open-label investigation comparing two UKCA/CE-marked Transanal Irrigation (TAI) products for the management of Faecal Incontinence (FI) and/or Chronic Constipation (CC) of heterogenous origin. The study will be conducted at up to 8 sites in the United Kingdom only.
The investigational device is the Qufora QNova. The comparator device is a Qufora IrriSedo Klick balloon catheter, with the same intended purpose as the investigational device. Both systems enable self-holding, hands-free irrigation, but they differ in their approach: the balloon catheter relies on instilling water into the balloon (managed by the control unit), which requires multiple steps whereas the investigational device provides self holding ability, due to its droplet-shaped design. The investigational design allows an exploratory assessment of two self-holding mechanisms used in current practice.
The aim of this investigation is to assess outcomes in a real-world clinical setting, by following the typical clinical routine, with randomisation and more frequent visits/phone calls as the only difference from typical clinical procedure.Participants will be randomised 1:1 to QNova or Klick after enrolment, with 66 participants in total (33 per arm). Enrolment is expected to take approximately 7 months. The duration of the training period is 4 weeks and the participant’s involvement is approximately 12 months. The total expected duration of the clinical investigation is approximately 22 months.
REC name
West of Scotland REC 4
REC reference
26/WS/0085
Date of REC Opinion
12 Jun 2026
REC opinion
Unfavourable Opinion