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To evaluate the efficacy and safety of single-use electronic biliary endoscopic catheter (RP-H-C21) for observation, diagnosis, photography, and treatment of the biliary tract: a prospective, randomized, parallel controlled, open, multicenter and non-inferior clinical trial

To evaluate the efficacy and safety of single-use electronic biliary endoscopic catheter (RP-H-C21) for observation, diagnosis, photography, and treatment of the biliary tract: a prospective, randomized, parallel controlled, open, multicenter and non-inferior clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127409
Enrollment
Unknown
Registered
2026-06-30
Start date
2022-03-15
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholelithiasis

Interventions

Control group (fiberoptic cholangioscopy group):Fiberoptic cholangioscopy
Test group (digital cholangioscopy group):Digital cholangioscopy

Sponsors

Zhujiang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Men or wome,18 to 75 years old. 2. Persons that fibrobiliary endoscope examinations or treatments are in need. 3. Persons that are voluntary to participate in this clinical trial, with written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with cirrhosis ascites. 2. Patients with bleeding tendencies. 3. Patients with unstable or complicated diseases, including acute biliary tract infections, organ failures, malignant tumors, and hypoproteinemia (albumin <30g/L). 4. Pregnant or lactating women. 5. Patients with mental illness. 6. Patients that have participated in other clinical trials 30 days before the enrollment. 7. Patients that are not appropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
The image quality compliance rate for clinical diagnostic requirement (center evaluation);

Secondary

MeasureTime frame
Instrument performance score;Instrument safety evaluation;

Countries

China

Contacts

Public ContactKebo Zhong; Yi Gao

Zhujiang Hospital of Southern Medical University

zhongkb@smu.edu.cn+86 13611467516

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026