Active magnetically controlled capsule endoscopy for small bowel navigation
Active Locomotion of Magnetically Controlled Capsule Endoscopy With Small Bowel Insufflation or Water Infusion: A Feasibility Study
NA · Shandong University · NCT07325344
We will test whether a handheld magnetic controller can steer a capsule endoscope through the small bowel in patients already scheduled for enteroscopy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Sex | All |
| Sponsor | Shandong University (other) |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT07325344 on ClinicalTrials.gov |
What this trial studies
Patients undergoing double-balloon enteroscopy will have a magnetically controlled capsule introduced while the endoscopist uses standard air insufflation or water infusion. A handheld attitude controller will be used to attempt active locomotion of the capsule within the small bowel. Real-time video from both the enteroscope and the capsule will be recorded and compared to determine responsiveness and controllability. The trial is a feasibility interventional protocol to characterize how reliably the capsule follows magnetic steering during routine enteroscopy procedures.
Who should consider this trial
Good fit: Ideal candidates are patients already scheduled for enteroscopy who can provide informed consent and do not have implanted electronic or metal devices, severe organ dysfunction, pregnancy, or contraindications to bowel preparation.
Not a fit: Patients with implanted pacemakers or metal implants, significant organ failure, small bowel obstruction, multiple prior major abdominal surgeries, pregnancy or lactation, or inability to consent are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could enable controlled navigation of capsule endoscopes to improve lesion localization and diagnostic yield in small bowel disease.
How similar studies have performed: Magnetically controlled capsule endoscopy has shown feasibility in gastric applications and some exploratory work in the small bowel, but combining handheld magnetic steering with simultaneous double-balloon enteroscopy imaging is relatively novel and primarily exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled to undergo enteroscopy. Exclusion Criteria: * 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.
Where this trial is running
Jinan, Shandong
- Qilu Hospital of Shandong University — Jinan, Shandong, China (RECRUITING)
Study contacts
- Study coordinator: Xiuli Zuo, MD,PhD
- Email: zuoxiuli@sdu.edu.cn
- Phone: +86-18560080066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Capsule Endoscopy, capsule endoscopy, small bowel disease, locomotion