Safety and Efficacy of Endoscopic Full Thickness Biopsy in Patients With Chronic Intestinal Pseudo-obstruction

NCT ID: NCT06943417

Last Updated: 2025-04-24

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2030-03-31

Brief Summary

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

Detailed Description

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Conditions

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Chronic Intestinal Pseudo-obstruction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Over the scope clip

Group Type EXPERIMENTAL

Over the scope clip

Intervention Type DEVICE

over the scope clip group

Interventions

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Over the scope clip

over the scope clip group

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International University of Health and Welfare

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

International university of health and welfare Narita hospital

Locations

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International university health and welfare Narita hospital

Narita, , Japan

Site Status

Countries

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Japan

Central Contacts

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

Role: CONTACT

+81-476-35-5600 ext. 900538

Yo Ishihara, M.D.

Role: CONTACT

+81-476-35-5600

Other Identifiers

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24-CN-021

Identifier Type: -

Identifier Source: org_study_id

UMIN000057266

Identifier Type: REGISTRY

Identifier Source: secondary_id

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