NCT06943417

Brief Summary

To evaluate the safety and efficacy of endoscopic full thickness biopsy for the diagnostic purpose of chronic intestinal pseudo-obstruction.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
47mo left

Started Jun 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Jun 2025Mar 2030

First Submitted

Initial submission to the registry

March 13, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2030

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

4.7 years

First QC Date

March 13, 2025

Last Update Submit

April 16, 2025

Conditions

Chronic Intestinal Pseudo-obstruction

Keywords

Chronic intestinal pseudo-obstructionEndoscopic full thickness biopsy

Outcome Measures

Primary Outcomes (1)

  • Percentage of total perforations (intraoperative and delayed perforations)

    Percentage of total perforations (intraoperative and delayed perforations)

    Immediately after the intervention

Secondary Outcomes (12)

  • Intraoperative perforation rate

    Under procedure

  • Rate of delayed perforation

    Periprocedural

  • Intraoperative complications

    Under procedure

  • Intraoperative death rate

    Under procedure

  • Examination time

    Under procedure

  • +7 more secondary outcomes

Study Arms (1)

Over the scope clip

EXPERIMENTAL
Device: Over the scope clip

Interventions

Over the scope clipDEVICE

over the scope clip group

Over the scope clip

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic pseudo intestinal obstruction or suspected chronic pseudo intestinal obstruction
  • Patients who are 18 years of age or older at the time of obtaining consent
  • Gender: Any

You may not qualify if:

  • Patients for whom it is difficult to perform endoscopy
  • Patients who cannot obtain consent
  • Patients with serious renal, hepatic, or cardiac disease
  • Patients who are participating in other clinical research, except for observational research.
  • Other patients whom the principal investigator or subinvestigator determines to be inappropriate to conduct this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International university health and welfare Narita hospital

Narita, Japan

Location

Study Officials

  • Takaomi Kessoku, M.D., Ph.D.

    International university of health and welfare Narita hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Takaomi Kessoku, M.D., Ph.D.

CONTACT

+81-476-35-5600takaomi0027@gmail.com

Yo Ishihara, M.D.

CONTACT

+81-476-35-5600

Study Design

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

Study Record Dates

First Submitted

March 13, 2025

First Posted

April 24, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

March 1, 2030

Last Updated

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)