NCT07325344

Brief Summary

The aim of this study is to evaluate the responsiveness of the capsule endoscope to the attitude controller and to investigate its active locomotion performance within the small bowel.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Dec 2025Dec 2026

Study Start

First participant enrolled

December 1, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

December 16, 2025

Last Update Submit

January 7, 2026

Conditions

Keywords

capsule endoscopysmall bowel diseaselocomotion

Outcome Measures

Primary Outcomes (1)

  • capsule endoscope's responsiveness to the attitude controller

    Excellent: The magnetically controlled capsule endoscope can precisely follow the attitude controller to move to the target area. Moderate: The magnetically controlled capsule endoscope can follow the attitude controller's movement, but cannot be accurately guided to the target area. Poor: There are signs of magnetic attraction, but the capsule does not follow the movement of the attitude controller.

    During performing double-balloon enteroscope

Study Arms (1)

subject

EXPERIMENTAL

During the routine air/water insufflation phases of the enteroscopy, the researchers will attempt to guide the capsule's movement using an external magnetic control device.

Device: magnetic control

Interventions

Intervention: On the day of the examination, the subject will swallow the capsule endoscope. This will be followed by a standard enteroscopy procedure. During the routine air/water insufflation phases of the enteroscopy, the researchers will attempt to guide the capsule's movement using an external magnetic control device.

subject

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled to undergo enteroscopy.

You may not qualify if:

  • Patients with severe dysfunction of vital organs (e.g., heart, lungs). Patients with small bowel obstruction precluding adequate bowel preparation. Patients with a history of multiple abdominal surgeries. Patients with implanted devices such as cardiac pacemakers or metal implants. Patients with other high-risk conditions or lesions (e.g., moderate-to-severe esophagogastric varices, massive ascites).
  • Patients who are pregnant or lactating. Patients unable or unwilling to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Central Study Contacts

Xiuli Zuo, MD,PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastroenterology Department

Study Record Dates

First Submitted

December 16, 2025

First Posted

January 8, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 8, 2026

Record last verified: 2026-01

Locations