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

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.

Study Overview

• Status: Completed
• Conditions: Pilot Study; Clips

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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100071
      • The Fifth Medical Center of Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Meet the inclusion and exclusion criteria.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate	Technical success rate refers to the ratio of cases in which a sufficient number of clips are placed and released.	The operation day
Delayed bleeding rate	The delayed bleeding rate is defined as the ratio of bleeding that necessitates emergency endoscopic hemostasis or transfusion, or the presence of hemoglobin loss of ≥2 g/dL after therapy.	14 days
Delayed perforation rate	The delayed perforation rate is defined as the ratio of the presence of free air on abdominal CT or radiography after the completion of the procedure in patients without perforation during EMR/ESD and no symptoms of peritoneal irritation after therapy.	14 days

Collaborators and Investigators

• Sponsor: Beijing 302 Hospital
• Investigators: Principal Investigator: Yan Liu, MD, The Fifth Medical Center of Chinese PLA General Hosptial

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: fistula; gastrointestinal bleeding; perforation; gastrointestinal diseases; clips; Metal-reinforced teeth
• Other Study ID Numbers: 307-reinforced teeth

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No