Clinical Trial of Metal-Reinforced Teeth Designed for Endoscopic Clips

Beijing 302 Hospital10 enrolled

Overview

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.

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

Conditions

Pilot Study

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 14 to 30 days

Secondary Outcomes

Technical success rate

Technical success rate refers to the ratio of cases in which a sufficient number of clips are placed and released.

Time frame: 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.

Time frame: 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.