NCT06285955

Clinical Trial of Metal-Reinforced Teeth Designed for Endoscopic Clips

Clinical Trial of Metal-reinforced Teeth Designed for Endoscopic Clips to Validate the Safety, Feasibility and Effectiveness

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Beijing 302 Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2024-02-15
• Primary completion: 2024-06-30
• Completion: 2024-07-31
• First posted: 2024-02-29
• Last updated: 2024-08-23

Locations

1 site across 1 country: China