Clinical Trial of Metal-Reinforced Teeth Designed for Endoscopic Clips

Pilot Study Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06285955
• Other study ID #: 307-reinforced teeth
• Status: Recruiting
• Start date: January 15, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2024
• Source: Beijing 302 Hospital
• Contact: Yan Liu, MD
• Phone: +8613911798288
• Email: 13911798288[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pilot Study

Locations

Country	Name	City	State
China	The fifth Medical Center of Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing 302 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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