An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.

Dentsply

Status: Completed

Conditions: Neurogenic Bowel

Treatments: Device: Navina Smart

Study type: Interventional

Funder types: Industry

Identifiers

NCT02979808

NAV-0001

Details and patient eligibility

About

This study is designed as an open, prospective, non-controlled, qualitative, multicentre study of a novel transanal irrigation system performed in a population of 150 subjects suffering from spinal cord injury and confirmed neurological bowel dysfunction. The study is expected to last for a total of 1 year (treatment period) with a planned 12- month recruitment period and three scheduled site visits.

Full description

This study will be conducted in multiple countries, all outside of the United States. The study is approved by oversight authorities in the United Kingdom, Germany, Spain, Sweden, Denmark, Norway, France, and Italy

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provision of informed consent.

2. Male or female aged 18 years or older.

3. Patient with previously confirmed chronic spinal cord injury, either:

   1. Traumatic; at any level and any completeness of injury and ASIA grade classification, or
   2. Non-traumatic; due to infection, inflammation (i.e.; transverse myelitis or ischaemic myelitis), compromised blood supply, a post-ischemic state, etc.

4. At least 3 months post spinal cord injury at time of consent.

5. NBD score ≥10, confirmed at Baseline .

6. Only TAI treatment - naïve patient (not having previously used any particular transanal irrigation system, e.g. Peristeen®).

7. Confirmed NBD refractory to conservative therapy and judged eligible for transanal irrigation as per standardised treatment pathway 18.

8. Able to handle smartphone/tablet.

Exclusion criteria

1. Any confirmed or suspected diagnosis of anal or rectal stenosis, active inflammatory bowel disease, acute diverticulitis, severe diverticulosis, colorectal cancer, ischemic colitis, history of life-threatening autonomic dysreflexia, bleeding disorders, unspecified peri-anal conditions.
2. Untreated rectal impaction.
3. Any radiotherapy to the pelvis.
4. Any current treatment with anticoagulants (not including aspirin or clopidogrel).
5. Any current treatment with long-term systemic steroid medication (not including inhalation agents and/or local topical treatment).
6. Current use of prokinetics.
7. Any prior rectal or colonic surgery (not including anal procedures >3 months ago, e.g. haemorrhoid excision).
8. Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks.
9. Overt or planned pregnancy.
10. Ongoing symptomatic UTI as judged by investigator.
11. Diagnosed psychiatric illness, considered as unstable by the investigator.
12. Diagnosed with MS.
13. Involvement in the planning and conduct of the study (applies to both WHC staff and staff at the study site).
14. Previous enrolment in the present study.
15. Simultaneous participation in another clinical study that may interfere with the present study.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Navina Smart

Experimental group

Description:

Navina Smart will be used during 12 months for transanal irrigation (TAI).

Treatment:

Device: Navina Smart