Chronic Intestinal Pseudo-obstructionEFTB-CIPONCT06943417
Safety and Efficacy of Endoscopic Full Thickness Biopsy in Patients With Chronic Intestinal Pseudo-obstruction
A study testing Over the scope clip in people with Chronic Intestinal Pseudo-obstruction, run by International University of Health and Welfare at 1 site in Japan.
Trial summary
To evaluate the safety and efficacy of endoscopic full thickness biopsy for the diagnostic purpose of chronic intestinal pseudo-obstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Intestinal Pseudo-obstruction
- What is being tested?
- Over the scope clip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jun 2025to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yo Ishihara, M.D. contact
About this study
Official title: Safety and Efficacy of Endoscopic Full Thickness Biopsy With Over the Scope Clip in Patients With Chronic Intestinal Pseudo-obstruction: A Single-Center, Single-Arm, Open-label, Interventional Trial
To evaluate the safety and efficacy of endoscopic full thickness biopsy for the diagnostic purpose of chronic intestinal pseudo-obstruction.
- Conditions
- Chronic Intestinal Pseudo-obstruction
- Being tested
- Over the scope clip
- Keywords
- Chronic intestinal pseudo-obstruction, Endoscopic full thickness biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Over the scope clipDevice
over the scope clip group
| Study group | Role | What they receive |
|---|---|---|
| Over the scope clip | Experimental | Not described Receives: Device: Over the scope clip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of total perforations (intraoperative and delayed perforations)
Percentage of total perforations (intraoperative and delayed perforations)
Measured: Immediately after the intervention
Secondary outcomes (12)
Intraoperative perforation rate
Intraoperative perforation rate
Measured: Under procedure
Rate of delayed perforation
Rate of delayed perforation
Measured: Periprocedural
Intraoperative complications
Intraoperative complications
Measured: Under procedure
Intraoperative death rate
Intraoperative death rate
Measured: Under procedure
Examination time
Examination time
Measured: Under procedure
Macroscopic specimen size
Macroscopic specimen size
Measured: Immediately after procedure
Findings of tissue specimens
Findings of tissue specimens
Measured: Immediately after procedure
Whether tissue evaluation is acceptable for biopsy purposes
Whether tissue evaluation is acceptable for biopsy purposes
Measured: Immediately after procedure
Ratio of postoperative complications
Ratio of postoperative complications
Measured: Immediately after procedure
Time or days of fluid intake postoperatively
Time or days of fluid intake postoperatively
Measured: From date of procedure until the date of first fluid intake assessed up to 12 months
Time or number of days of food intake after procedure
Time or number of days of food intake after procedure
Measured: From date of procedure until the date of first food intake assessed up to 12 months
Length of hospital stay
Length of hospital stay
Measured: From date of procedure until the date of discharge assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completionFeb 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Intestinal Pseudo-obstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International University of Health and Welfare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Takaomi Kessoku, M.D., Ph.D., Principal investigator, International university of health and welfare Narita hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943417
- Sponsor's protocol ID
- 24-CN-021
- Other IDs
- UMIN000057266
- Acronym
- EFTB-CIPO
- Status last verified
- Apr 2025
- First submitted
- 13 Mar 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Endoscopic Full Thickness Biopsy With Over the Scope Clip in Patients With Chronic Intestinal Pseudo-obstruction: A Single-Center, Single-Arm, Open-label, Interventional Trial
- ClinicalTrials.gov ID
- NCT06943417
- Acronym / sponsor ID
- EFTB-CIPO / 24-CN-021
- Conditions
- Chronic Intestinal Pseudo-obstruction
- Keywords
- Chronic intestinal pseudo-obstruction, Endoscopic full thickness biopsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- International University of Health and WelfareUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of endoscopic full thickness biopsy for the diagnostic purpose of chronic intestinal pseudo-obstruction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Over the scope clip | Experimental | Device: Over the scope clip |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Over the scope clipover the scope clip group | Device | Over the scope clip |
Primary outcome
Percentage of total perforations (intraoperative and delayed perforations)
Time frame: Immediately after the intervention
Percentage of total perforations (intraoperative and delayed perforations)
12 secondary outcomes
Intraoperative perforation rate
Time frame: Under procedure
Rate of delayed perforation
Time frame: Periprocedural
Intraoperative complications
Time frame: Under procedure
Intraoperative death rate
Time frame: Under procedure
Examination time
Time frame: Under procedure
Macroscopic specimen size
Time frame: Immediately after procedure
Findings of tissue specimens
Time frame: Immediately after procedure
Whether tissue evaluation is acceptable for biopsy purposes
Time frame: Immediately after procedure
Ratio of postoperative complications
Time frame: Immediately after procedure
Time or days of fluid intake postoperatively
Time frame: From date of procedure until the date of first fluid intake assessed up to 12 months
Time or number of days of food intake after procedure
Time frame: From date of procedure until the date of first food intake assessed up to 12 months
Length of hospital stay
Time frame: From date of procedure until the date of discharge assessed up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yo Ishihara, M.D. contact
Takaomi Kessoku, M.D., Ph.D. principal investigator
International university of health and welfare Narita hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Over the scope clip in people with Chronic Intestinal Pseudo-obstruction, run by International University of Health and Welfare at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takaomi Kessoku, M.D., Ph.D. (+81-476-35-5600 ext. 900538, takaomi0027@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of total perforations (intraoperative and delayed perforations) (time frame: Immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.