Capsule EndoscopyNCT07325344
Active Locomotion of Magnetically Controlled Capsule Endoscopy in the Small Bowel: A Feasibility Study
A study of Capsule Endoscopy, run by Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Capsule Endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 31 Dec 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled to undergo enteroscopy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Xiuli Zuo, MD, PhD, +86-18560080066, zuoxiuli@sdu.edu.cn
About this study
Official title: Active Locomotion of Magnetically Controlled Capsule Endoscopy With Small Bowel Insufflation or Water Infusion: A Feasibility Study
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.
Read the detailed description
During the standard air insufflation or water infusion phases of double-balloon enteroscopy, researchers will use a handheld controller to try to steer the capsule. At the same time, the real-time imaging from both the enteroscope and the capsule will be simultaneously monitored to assess the capsule's active movement and its responsiveness to control.
- Conditions
- Capsule Endoscopy
- Being tested
- magnetic control
- Keywords
- capsule endoscopy, small bowel disease, locomotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic controlDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: magnetic control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During performing double-balloon enteroscope
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Capsule EndoscopyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325344
- Sponsor's protocol ID
- KYLL-2025-10-008-1
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Locomotion of Magnetically Controlled Capsule Endoscopy With Small Bowel Insufflation or Water Infusion: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07325344
- Acronym / sponsor ID
- KYLL-2025-10-008-1
- Conditions
- Capsule Endoscopy
- Keywords
- capsule endoscopy, small bowel disease, locomotion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Jan 2026 (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.
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.
Detailed description
During the standard air insufflation or water infusion phases of double-balloon enteroscopy, researchers will use a handheld controller to try to steer the capsule. At the same time, the real-time imaging from both the enteroscope and the capsule will be simultaneously monitored to assess the capsule's active movement and its responsiveness to control.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subject | Experimental | Device: magnetic controlDuring 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled to undergo enteroscopy.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| magnetic controlIntervention: 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. | Device | subject |
Primary outcome
capsule endoscope's responsiveness to the attitude controller
Time frame: During performing double-balloon enteroscope
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.
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 8 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Capsule Endoscopy, run by Shandong University at 1 site in China.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Jan 2026. 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 China. 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 Xiuli Zuo, MD,PhD (+86-18560080066, zuoxiuli@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
capsule endoscope's responsiveness to the attitude controller (time frame: During performing double-balloon enteroscope). 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 8 Jan 2026.