Clinical trial NCT06285955: Clinical Trial of Metal-Reinforced Teeth Designed for Endoscopic Clips
Official title: Clinical Trial of Metal-reinforced Teeth Designed for Endoscopic Clips to Validate the Safety, Feasibility and Effectiveness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pilot Study
Clips
Keywords: clips
gastrointestinal diseases
Metal-reinforced teeth
perforation
fistula
gastrointestinal bleeding
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Meet the inclusion and exclusion criteria.

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.

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.

Primary outcomes:
measure: Clinical success rate
timeFrame: 14 to 30 days
Secondary outcomes:
measure: Technical success rate
timeFrame: The operation day
measure: Delayed bleeding rate
timeFrame: 14 days
measure: Delayed perforation rate
timeFrame: 14 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: The fifth Medical Center of Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: The Fifth Medical Center of Chinese PLA General Hosptial
name: Yan Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: