A prospective, randomized controlled, non-inferiority clinical trial to evaluate the efficacy and safety of plasma radiofrequency generator with polypectomy snare for cutting and clotting tissues in the digestive tract
Phase 1
Completed
- Conditions
- digestive tract disease
- Registration Number
- ChiCTR2000041576
- Lead Sponsor
- Zhongshan Hospital Affiliated to Fudan University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Able to understand and willing to participate in this clinical trial, and voluntarily sign the informed consent;<br>2. Ages >= 18 years and <= 70 years, male or female;<br>3. Patients who need EMR (Endoscopic Mucosal Resection) procedure;<br>4. Has no more than 5 lesions of 8 - 20 mm in size;<br>If the answer to any one question above is No, the patient shall be excluded from this clinical trial.
Exclusion Criteria
- Patient with coagulations disorders which is the contraindication to surgical procedures, or is still taking anticoagulant one week before surgery. <br>2. Patient with severe cardiopulmonary insufficiency who cannot tolerate the operation;<br>3. Women of childbearing age with blood pregnancy or urine pregnancy test yielding a positive result, or in lactation period;<br>4. Patient with cardiac pacemakers or other electronic implants;<br>5. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation of the study.<br>If the answer to any one question above is Yes, the patient shall be excluded from this clinical trial.<br>Note: Coagulation disorder is indicated by prolonged Prothrombin Time (PT) for more than 3 seconds (5 seconds if patient has liver disease), or prolonged activated partial thromboplastin time (APTT) for more than 10 seconds, or Platelet count (PLT) is less than 70 x 10^9/L.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method En bloc resection success rates;
- Secondary Outcome Measures
Name Time Method Success rate of coagulation;Device performance evaluation;Incidence of bleeding during operation;Incidence of perforation during operation;Incidence of bleeding post-toperative;Incidence of perforation post-operation;