Investigation of a New Rectal Catheter for Users of Transanal Irrigation

Coloplast

Status: Completed

Conditions: Bowel Management

Treatments: Device: CP362 Test Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT06389396

CP362

Details and patient eligibility

About

The clinical investigation is an exploratory, randomised controlled, open-labelled, crossover investigation.

The clinical investigation will be conducted as a multi-centre clinical investigation in two different clinical investigation sites in Denmark.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Has given written Informed Consent
2. Is at least 18 years old
3. Has full legal capacity
4. Has used Trans Anal Irrigation (TAI) with balloon catheter for at least 4 weeks prior to inclusion
5. Performs TAI minimum 3 times/week
6. Is able to follow study procedures assessed by investigator

Exclusion criteria

1. Has known anal or colorectal stenosis
2. Has active/recurrent colorectal cancer
3. Is within 3 months of anal or colorectal surgery
4. Is within 4 weeks of endoscopic polypectomy
5. Has ischaemic colitis
6. Has acute inflammatory bowel disease
7. Has acute diverticulitis
8. Is participating in any other clinical study that may interfere with this study (assessed by investigator).
9. Is pregnant or breastfeeding

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Investigational device - newly developed TAI catheter.

Experimental group

Description:

CP362 Test Catheter: The investigational device is intended to perform TAI procedures together with the CE-marked Peristeen® Plus TAI system.

Treatment:

Device: CP362 Test Catheter

Peristeen Plus

No Intervention group

Description:

Comparator catheter: The Peristeen® Plus rectal balloon catheter is used together with the CE-marked Peristeen® Plus TAI system.