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

NCT ID: NCT02979808

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Neurogenic Bowel

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Navina Smart

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

Group Type EXPERIMENTAL

Navina Smart

Intervention Type DEVICE

Subjects treatment-naïve to transanal irrigation (TAI). Frequency of TAI will be tailored to each subject.

Interventions

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Navina Smart

Subjects treatment-naïve to transanal irrigation (TAI). Frequency of TAI will be tailored to each subject.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wellspect HealthCare

INDUSTRY

Sponsor Role collaborator

Dentsply International

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Hôpital St Jacques

Nantes, Rennes, France

Site Status

Zentralklinik Bad Berka Gmbh

Bad Berka, , Germany

Site Status

BG-Klinikum Hamburg

Hamburg, , Germany

Site Status

Montecatone Rehabilitation Institute, Università di Bologna

Imola, Bologna, Italy

Site Status

Azienda Ospedaliera- Universitaria Careggi

Florence, Florence, Italy

Site Status

Sunnaas Sykehus HF

Nesoddtangen, , Norway

Site Status

Complejo Hospitalario Universitario A Coruña

A Coruña, , Spain

Site Status

Unidad de Lesionados Medulares Hospital Traumatología

Barcelona, , Spain

Site Status

Neurologiska kliniken, Avd R18 Karolinska Universitetssjukhuset, Solna

Stockholm, , Sweden

Site Status

Gastrointestinal Physiology Unit, University College London Hospital

London, , United Kingdom

Site Status

Countries

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Denmark France Germany Italy Norway Spain Sweden United Kingdom

References

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Emmanuel A, Kurze I, Krogh K, Ferreiro Velasco ME, Christensen P, Del Popolo G, Bazzocchi G, Hultling C, Perrouin Verbe B, Bothig R, Glott T, Gonzalez Viejo MA. An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction. PLoS One. 2021 Jan 29;16(1):e0245453. doi: 10.1371/journal.pone.0245453. eCollection 2021.

Reference Type DERIVED
PMID: 33513187 (View on PubMed)

Other Identifiers

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NAV-0001

Identifier Type: -

Identifier Source: org_study_id