Skip to content

A prospective, randomized, single-blind, parallel-controlled, single-center study to evaluate the effectiveness of EndoAngel in improving the detection of high-risk esophageal lesions

A prospective, randomized, single-blind, parallel-controlled, single-center study to evaluate the effectiveness of EndoAngel in improving the detection of high-risk esophageal lesions

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100044126
Enrollment
Unknown
Registered
2021-03-11
Start date
2021-03-22
Completion date
Unknown
Last updated
2021-07-21

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

Conditions

High risk lesions in Esophageal squamous cell carcinoma

Interventions

Group 1 vs. Group 2:EndoAngel assisted esophagogastroscopy vs. conventional esophagogastroscopy

Sponsors

Renmin Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Male or female aged 50 years or above; 2) Able to read, understand and sign informed consent; 3) The investigator believes that subjects can understand the process of the clinical study, are willing and able to complete all the study procedures and follow-up visits, and cooperate with the study procedures.

Exclusion criteria

Exclusion criteria: 1) Patients with known esophageal cancer; 2) Patients with absolute contraindications to esophagogastroscopy; 3) Patients with contraindications to biopsy; 4) patients with esophageal surgery, radiotherapy, chemotherapy, radiotherapy or chemotherapy history; 5) Patients with suspected active upper gastrointestinal bleeding; 6) Pregnant or lactating women; 7) Patients with known or suspected upper gastrointestinal obstruction 8) Previous failed esophagogastroscopy; 9) High-risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.

Design outcomes

Primary

MeasureTime frame
High Risk Lesion Detection Rate;

Secondary

MeasureTime frame
Detection rate of high risk lesions in cervical, thoracic and abdominal segments of esophagus;Detection rate of advanced esophageal cancer;Detection rate of early esophageal cancer;Detection rate of precancerous lesions;Detection rate of low risk lesions;Adverse events (AES) and serious adverse events (SAEs);

Countries

China

Contacts

Public ContactLi-Ping Ye

Zhejiang Province affiliated to Wenzhou Medical University

yelp@enzemed.com+86 13566866269

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026