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A multicenter, randomized, crossover, controlled study for 3D imaging devices for the diagnosis of gastric cancer and precancerous lesions

A multicenter, randomized, crossover, controlled study for 3D imaging devices for the diagnosis of gastric cancer and precancerous lesions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025003
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

Gastric cancer and precancerous lesions

Interventions

Gold Standard:Pathological examination
Index test:1.&#32
imaging&#32
gastroscopy
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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 gastroscopyand receiving diagnostic gastroscopy; (3)Signing the written informed consent.

Exclusion criteria

Exclusion criteria: (1)Patients with a history of digestive tract cancer or stomach surgery; (2)Patients with active gastrointestinal bleeding; (3)Patients with severe cardiopulmonary insufficiency; (4)Patients with abnormal coagulation or anticoagulant therapy; (5)Patients with mental illness or severe functional disorder who cannot cooperate with gastroscopy; (6)Pregnancy and lactation; (7)Unwilling to participate in this study

Design outcomes

Primary

MeasureTime frame
Gastric cancer and precancerous lesions detection rate;

Secondary

MeasureTime frame
Gastric cancer and precancerous lesions detection rate in different location;Gastric cancer and precancerous lesions detection rate in different size;Gastric cancer and precancerous lesions detection rate in different type;Operator experience;Incidence of adverse events;SEN, SPE, ACC, AUC of ROC;

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