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A clinical study to evaluate the efficacy and safety of InnerMedical endoscopic ultrasound system in upper gastrointestinal examination

A clinical study to evaluate the efficacy and safety of InnerMedical endoscopic ultrasound system in upper gastrointestinal examination

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900027353
Enrollment
Unknown
Registered
2019-11-10
Start date
2019-11-12
Completion date
Unknown
Last updated
2019-11-11

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

Conditions

Upper digestive tract disease

Interventions

Gold Standard:Olympus endoscopic ultrasound
Index test:InnerMedical&#32
ultrasound&#32
system&#32

Sponsors

Nanfang Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) patients who proposed upper gastrointestinal endoscopy; (2) aged 18 to 70 years, male or female; (3) no cognitive dysfunction; (4) voluntary participation in this clinical trial, informed consent has been signed.

Exclusion criteria

Exclusion criteria: (1) American society of anesthesiologists (ASA) grades III ~ VI. (2) long-term use of anticoagulant therapy or the use of anticoagulant drugs within 1 week before enrollment; Or patients with a history of drug abuse, allergy to sedatives, or other risks of anesthesia. (3) severe spine or thoracic deformity. (4) severe history of esophageal and gastric varicose veins. (5) the anatomical structure of pharynx/esophagus/stomach/duodenum is obviously malformed/narrow. (6) patients with massive gastrointestinal bleeding or suspected gastrointestinal perforation or erosive esophageal burns in the acute stage or edema stage. (7) patients with severe diseases of various systems, including but not limited to aortic aneurysm, cardiopulmonary insufficiency, and acute stage of stroke. (8) patients with pregnancy, lactation or recent family planning. (9) patients enrolled in other clinical trials within the first 30 days. (10) patients considered inappropriate by the investigator to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Overall image consistency;Complete machine safety;Vital signs;Adverse events;

Secondary

MeasureTime frame
Image quality rate;System stability;

Countries

China

Contacts

Public ContactLiu Side

Nanfang Hospital, Southern Medical University

liuside2011@163.com+86 020 61641537

Outcome results

None listed

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