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A multi-center, randomized, cross-sectional, and controlled study for 3D imaging devices in the diagnosis of esophageal cancer and precancerous lesions

A multi-center, randomized, cross-sectional, and controlled study for 3D imaging devices in the diagnosis of esophageal cancer and precancerous lesions

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025002
Enrollment
Unknown
Registered
2019-08-07
Start date
2019-08-09
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

Esophageal carcinoma and precancerous lesions

Interventions

Gold Standard:Pathological examination
Index test:1.&#32
imaging&#32
gastroscopy
&#32
2.&#32

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Aged 18-70 years; (2) Patients with indications for gastroscopy and receiving diagnostic gastroscopy; (3) Signing the written informed consent.

Exclusion criteria

Exclusion criteria: (1)Patients with history of gastrointestinal tumors or gastric surgery (2)Patients with active gastrointestinal bleeding (3)Patients with severe cardiopulmonary insufficiency; (4)Patients with abnormal coagulation function or receiving anticoagulation therapy (5)Patients with mental illness or severe functional disorder who cannot cooperate with gastroscopy; (6)Pregnancy and lactation.

Design outcomes

Primary

MeasureTime frame
Esophageal carcinoma and precancerous lesions detection rate;SEN, SPE, ACC, AUC of ROC;

Secondary

MeasureTime frame
Esophageal carcinoma and precancerous lesions detection rate in different location;Esophageal carcinoma and precancerous lesions detection rate in different type;Esophageal carcinoma and precancerous lesions detection rate in different size;Operator experience;Adverse event rate;

Countries

China

Contacts

Public ContactShutian Zhang

Beijing Friendship Hospital, Capital Medical University

zhangshutian@ccmu.edu.cn+86 13911021992

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026