Application of Multimodal Endoscopic Functional Imaging Technology in the Diagnosis of Common Gastrointestinal Diseases

NCT06236594 | Unknown DMC

• 1 other identifier: multimodal endoscopic imaging
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

We plan the study to explore the application of endoscopic laser speckle imaging and multispectral blood oxygen imaging to observe gastrointestinal lesions, as well as the differences in the morphology, density and functional status of mucosal surfaces and deep blood vessels of different gastrointestinal lesions, also to explore the role of endoscopic multimodal functional imaging in common gastrointestinal diseases, especially in the early diagnosis of gastrointestinal tumors.

Conditions

Gastrointestinal Disease

Keywords

endoscopic laser speckle imaging; multispectral blood oxygen imaging; gastrointestinal lesions; early diagnosis; gastrointestinal tumors

Outcome Measures

Primary Outcomes (1)

• Image quality rate

  The main evaluation index (image quality rate) is based on FAS(Full Analysis Set) and PPS(Per Protocol Set), for statistical description. Image quality rate Calculation formula: image excellent rate = number of cases with excellent or good image quality evaluation ÷ number of subjects undergoing multimodal endoscopy × 100%.

  one year

Secondary Outcomes (1)

• Diagnosis accuracy according to image

  one year

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Meet the inclusion and exclusion criteria.

You may qualify if:

• Age: 18-80 years old, gender is not limited
• Diagnosed or suspected of one of the following common gastrointestinal mucosal diseases: Chronic non-atrophic gastritis, chronic atrophic gastritis, gastric polyps, early gastric cancer, advanced gastric cancer, colon polyps, colon melanosis, inflammatory bowel disease, early colon cancer, advanced colon cancer
• Sign the informed consent form -

You may not qualify if:

• Combined with cardiovascular and cerebrovascular diseases, or severe impairment of liver, kidney and hematopoietic system;
• mentally ill;
• the presence of bleeding disorders;
• Platelet count\<50×10\^9/L;
• Inability to tolerate or cooperate with endoscopy;
• Patients with serious complications, such as severe infection, gastrointestinal bleeding, obstruction, perforation, etc.;
• Pregnant or lactating women.
• Refuse to sign the informed consent form

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (1)

The fifth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100071, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

After the acquisition of endoscopic images, endoscopic pathological biopsy is routinely performed for patients who consider the presence of mucosal lesions. Endoscopic mucosal resection (EMR) or submucosal dissection (ESD) is performed for inpatients in the Department of Gastroenterology according to clinical needs, and postoperatively the specimens will be sent to the Department of Pathology for further pathological analysis.

MeSH Terms

Conditions

Gastrointestinal Diseases; Disease; Digestive System Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms

Study Officials

• Yan Liu

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Shen

CONTACT

+8615001038695; shshenw@sina.com

Shujuan Li

CONTACT

+8601066947300

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: September 18, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

CN (1)