Exploratory Investigation on a Novel Catheter

NCT05644912 | Completed

• 1 other identifier: NAV-0010
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

An exploratory, pre-market, open, prospective, interventional, clinical investigation at a limited number of centers for proof of concept of a new catheter. In this proof of concept investigation, subjects experienced in using transanal irrigation (TAI) with a balloon catheter will be using study catheters at two occasions to primarily study if the catheter will stay in place during the water instillation when performing TAI. Each subject will be followed during approximately one week, depending on the usual time between their TAI.

Conditions

Bowel Dysfunction

Outcome Measures

Primary Outcomes (1)

• Catheter stay in place

  Does the catheter stay in place during water instillation? Yes/No

  1 week

Secondary Outcomes (2)

• Bowel emptying performance

  1 week

• Leakage

  1 week

Other Outcomes (1)

• Safety: Adverse Events and Device Deficiencies

  1 week

Study Arms (1)

All subjects

EXPERIMENTAL

Transanal irrigation (TAI) with new catheter

Device: Transanal irrigation (TAI)

Interventions

Transanal irrigation (TAI) DEVICE

Transanal irrigation (TAI) with new catheter on subjects experienced in using TAI with balloon catheter.

All subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent.
• Female and male aged 18-80 years.
• Patients successfully treated by TAI with Navina Smart system for at least 3 months and/or stable in therapy.
• Patients considered suitable to participate by investigator.
• Able to read, write and understand information given to them regarding the study.

You may not qualify if:

• Involvement in the planning and conduct of the clinical investigation (applies to both Wellspect HealthCare staff and staff at the study site).
• Previous enrolment in the present clinical investigation.
• Simultaneous participation in another clinical investigation, or participation in a clinical investigation during the last month, that may interfere with the present clinical investigation.
• Severe non-compliance to Clinical Investigation Plan as judged by the investigator and/or Wellspect HealthCare.
• Significant cardiovascular and/or other significant co-morbidities which could be negatively affected by the use of the investigational product.
• Known anal or colorectal stenosis.
• Active inflammatory bowel disease.
• Acute diverticulitis.
• Colorectal cancer.
• Ischemic colitis.
• Any anal or colorectal surgery within the previous 3 months.
• Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks.
• Any condition, as judged by the investigator, which might make follow-up or investigations inappropriate.
• Any patient that according to the Declaration of Helsinki is unsuitable for enrolment.

Sponsors & Collaborators

• Wellspect HealthCare: lead

Study Sites (1)

Proctos Kliniek

Bilthoven, MB Bilthoven, 3723, Netherlands

Location

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Ingrid Han-Geurts, MD

  Proctos Kliniek

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Proof of concept investigation with subjects experienced in using transanal irrigation with a balloon catheter.

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 9, 2022
• Study Start: November 18, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: April 24, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)