Clinical Trial of Metal-Reinforced Teeth Designed for Endoscopic Clips

NCT06285955 | Completed

• 1 other identifier: 307-reinforced teeth
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative gastrointestinal complications following ESD, EMR, and EFTR procedures, such as gastrointestinal bleeding, diverticula, fistulas, perforations, and stent fixation, can be effectively treated through gradual endoscopic procedures. The technical limitations of traditional endoscopic hemoclips restrict their application. Although endoscopic suturing techniques are emerging, most are still in the exploratory phase. Therefore, the investigators have developed metal-reinforced teeth for hemoclips. This initial clinical study aims to validate the safety, feasibility, and effectiveness of reinforced teeth in clinical applications. The investigators also aim to explore the uses and limitations of this technology. The primary outcomes are the technical success rate and the clinical success rate.

Conditions

Pilot Study; Clips

Keywords

clips; gastrointestinal diseases; Metal-reinforced teeth; perforation; fistula; gastrointestinal bleeding

Outcome Measures

Primary Outcomes (1)

• Clinical success rate

  Clinical success rate refers to the ratio of cases in which gastrointestinal problems have been resolved and/or endoscopic or radiological data show complete closure of the defect.

  14 to 30 days

Secondary Outcomes (3)

• Technical success rate

  The operation day

• Delayed bleeding rate

  14 days

• Delayed perforation rate

  14 days

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Meet the inclusion and exclusion criteria.

You may qualify if:

• \. Gastrointestinal lesions that require clips include non-variceal upper gastrointestinal bleeding, post-endoscopic submucosal dissection (ESD) lesions in the gastrointestinal tract, fistulas, diverticula, perforations, and anchoring of self-expanding metal stents.
• \. Expected survival greater than 30 days;
• \. Written informed consent.

You may not qualify if:

• \. Patients with diffuse gastrointestinal lesions, such as Crohn's disease and ulcerative colitis;
• \. Patients who clearly require surgical intervention;
• \. Serious cardio-pulmonary, hepatic or renal disease;
• \. Intolerance to endoscopy;
• \. Pregnant or lactating women.

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (1)

The fifth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100071, China

Location

MeSH Terms

Conditions

Gastrointestinal Diseases; Fistula; Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Hemorrhage; Pathologic Processes

Study Officials

• Yan Liu, MD

  The Fifth Medical Center of Chinese PLA General Hosptial

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 29, 2024
• Study Start: February 15, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-02

Locations

CN (1)