Composite Steep-pulseTreatment Device Used in Patients With Benign Prostatic Hyperplasia

• Status: Completed
• Trial end date: 2022-07-08
• Target enrollment: 0
• Participant gender: Male

Summary

This is a prospective, randomized, open-label, parallel-group, medication-control, superiority, multicenter clinical study trial.

This study is studying the effects and safety in treating patients from nine different centers with Benign prostatic hyperplasia, employing Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Apparatus. This device could cause cell irreversible electroporation, which leading necrosis of hyperplasia tissue cells. It also has the ability to prevent nerve,vessel, urethral and capsule unnecessary injury beside the ablation area. Composite Steep-pulse Treatment Apparatus will be used in patients who pass inclusion/exclusion criteria. Safety, quality of life, and urodynamic data analysis of each patient will be evaluated in each study patients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: REMD Medical Technology
• Collaborators: Dongfang Hospital Affiliated to Tongji University; Hunan Provincial People's Hospital; Ningbo No.2 Hospital; Qilu Hospital of Shandong University; RenJi Hospital; Shangdong Yiyuan Hospital; Shanghai Pudong Hospital; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; Tongji Hospital
• Treatments: Tamsulosin

Criteria

Inclusion Criteria:

1. Males between 50 to 80 years old;

2. Patients who Fully understand the treatment plan for irreversible electroporation, and accept the trial treatment and signed informed consent form;

3. International Prostate Symptom Score (IPSS)≥12;

4. Patients who have no willing to perform enucleation or transurethral resection of prostate;

5. Maximum urinary flow rate (Qmax) >5ml/min and ≤15ml/min, voided volume ≥150ml;

6. The volume of prostate was ≥30cm3 measured by MRI;

7. Patients who Could perform follow-up evaluation in accordance with the trial protocol.

Exclusion Criteria:

1. Patients with a history of prostate cancer, or who confirmed diagnosis of prostate cancer (needle biopsy of the prostate is required for patients indicated for needle aspiration, and if the needle result suggests benign prostatic hyperplasia, enrollment is allowed);

2. Patients with second-degree or higher atrioventricular block and other cardiac diseases with clear contraindications to anesthesia;

3. Patients with cardiac pacemakers and metallic replacement of pelvis or hip joints;

4. Patients who underwent previous prostate surgery for benign prostatic hyperplasia;

5. patients who have history of soft or rigid cystoscopy or other transurethral device use within 7 days prior to Informed Consent Form signed;

6. Any condition other than BPH that could lead to urinary symptoms or altered urinary flow rate (such as neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, acute or chronic urinary tract infection) as judged by the investigator;

7. Patients with a previous history of epilepsy;

8. Patients who have participated in other clinical trials within 3 months.

9. Patients with ASA (American Society of Anesthesiology) score 4 or above, such as malignant hypertension, recent myocardial infarction, active cerebrovascular accident, severe anemia and other contraindications to general anesthesia;

10. Patients who are considered to be inappropriate for participation in the trial by the investigator.