Clincosm LogoSign in Get a demo

Exploratory Investigation on a Novel Catheter

Sponsor
Wellspect HealthCare (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05644912
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
2.4
Anticipated Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transanal irrigation (TAI)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Proof of concept investigation with subjects experienced in using transanal irrigation with a balloon catheter.Proof of concept investigation with subjects experienced in using transanal irrigation with a balloon catheter.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Exploratory Investigation on a Novel Catheter
Actual Study Start Date :
Nov 18, 2022
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: All subjects

Transanal irrigation (TAI) with new catheter

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

Outcome Measures

Primary Outcome Measures

  1. Catheter stay in place [1 week]

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

Secondary Outcome Measures

  1. Bowel emptying performance [1 week]

    Evaluation of bowel emptying performance: Subject's perception of emptying of bowel similar to regular use of TAI. Descriptive analysis of data from questionnaires at Visit 2 and 3 collected from subject's previous experience from using balloon catheter comparing it with experience of using two different sizes of study catheters during study. Question asked: "What is the subject's perception of emptying of bowel with the study catheter compared to their regular use with a balloon catheter?" Potential response: much worse, worse, same, better, much better

  2. Leakage [1 week]

    Evaluation of leakage during water instillation: Subject's perception of leakage similar to regular use of TAI. Descriptive analysis of data from questionnaires at Visit 2 and 3 collected from subject's previous experience from using balloon catheter comparing it with experience of using two different sizes of study catheters during study. Question asked: "What is the subject's perception of leakage with the study catheter compared to their regular use with a balloon catheter?" Potential response: much worse, worse, same, better, much better

Other Outcome Measures

  1. Safety: Adverse Events and Device Deficiencies [1 week]

    To evaluate the safety of catheter by assessment of incidence and severity of Adverse Events (AEs, SAEs, ADEs, SADEs, USADEs) and Device Deficiencies occurring during the study period.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Provision of informed consent.

  2. Female and male aged 18-80 years.

  3. Patients successfully treated by TAI with Navina Smart system for at least 3 months and/or stable in therapy.

  4. Patients considered suitable to participate by investigator.

  5. Able to read, write and understand information given to them regarding the study.

Exclusion Criteria:

  1. Involvement in the planning and conduct of the clinical investigation (applies to both Wellspect HealthCare staff and staff at the study site).

  2. Previous enrolment in the present clinical investigation.

  3. Simultaneous participation in another clinical investigation, or participation in a clinical investigation during the last month, that may interfere with the present clinical investigation.

  4. Severe non-compliance to Clinical Investigation Plan as judged by the investigator and/or Wellspect HealthCare.

  5. Significant cardiovascular and/or other significant co-morbidities which could be negatively affected by the use of the investigational product.

  6. Known anal or colorectal stenosis.

  7. Active inflammatory bowel disease.

  8. Acute diverticulitis.

  9. Colorectal cancer.

  10. Ischemic colitis.

  11. Any anal or colorectal surgery within the previous 3 months.

  12. Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks.

  13. Any condition, as judged by the investigator, which might make follow-up or investigations inappropriate.

  14. Any patient that according to the Declaration of Helsinki is unsuitable for enrolment.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Proctos Kliniek Bilthoven MB Bilthoven Netherlands 3723

Sponsors and Collaborators

  • Wellspect HealthCare

Investigators

  • Principal Investigator: Ingrid Han-Geurts, MD, Proctos Kliniek

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wellspect HealthCare
ClinicalTrials.gov Identifier:
NCT05644912
Other Study ID Numbers:
  • NAV-0010
First Posted:
Dec 9, 2022
Last Update Posted:
Dec 9, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Intestinal Diseases

Study Results

No Results Posted as of Dec 9, 2022