Clinical Trial of Metal-Reinforced Teeth Designed for Endoscopic Clips

NCT ID: NCT06285955

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2024-07-31

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.

Detailed Description

With the advancement of endoscopic technology, gastrointestinal defects following endoscopic submucosal dissection (ESD), mucosal resection (EMR), and full-thickness resection (EFTR), as well as complications such as gastrointestinal bleeding, diverticula, fistulas, perforations, and even fixation of esophageal stents, can gradually be treated through endoscopic procedures. This approach avoids surgical incisions and reduces patient recovery time. Traditional endoscopic hemoclips have limited application due to constraints such as arm extension distance, size of the clip's front teeth, and closing force. 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 outcome measures include technical success rate and clinical success rate. Additionally, the investigators closely monitor procedure time, the number of clip uses during the procedure, and postoperative adverse events during follow-ups.

Conditions

Pilot Study; Clips

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 1. 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.
• 2. Expected survival greater than 30 days;
• 3. Written informed consent.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing 302 Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Liu, MD

Role: PRINCIPAL_INVESTIGATOR

The Fifth Medical Center of Chinese PLA General Hosptial

Locations

The fifth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

307-reinforced teeth

Identifier Type: -

Identifier Source: org_study_id