Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Gyrus ACMI, Inc. | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will prospectively evaluate a new electrosurgical procedure (bipolar transurethral prostatectomy) in men with symptomatic benign prostatic hyperplasia.
The purpose of this study is to demonstrate that the Bipolar TURP using the Vista Controlled Tissue Resection System is safe and efficacious as a surgical treatment for men with symptomatic BPH, allowing a reduction in the post-operative hospitalization. It is expected that bipolar TURP will be safe and efficacious for the surgical treatment of BPH and will allow a < 24 hour post-operative hospital stay in > 50% of patients undergoing this procedure.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Active Comparator | Bipolar Electrosurgical Unit |
|
| 1 | Active Comparator | Monopolar Electrosurgical Unit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bipolar Transurethral Resection of the Prostate | Procedure | Bipolar TURP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of efficacy will be determined by comparing pre and post-operative symptom scores. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pre and post-operative objective and subjective data for each treatment group will be assessed to determine safety and efficacy. Complications related to the surgical procedure will be noted by flexible cystoscopy at 6 months. | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hassan Razvi, MD, FRCSC | Urology, St. Joseph's Hospital, University of Western Ontario | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Urology Institute Research Centre | Edmonton | Alberta | T5H 4B9 | Canada | ||
| Prostate Centre at Vancouver General Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
| Monopolar Transurethral Resection of the Prostate | Procedure | Monopolar TURP |
|
|
| Vancouver |
| British Columbia |
| V5Z 3J5 |
| Canada |
| Can-Med Clinical Research Inc | Victoria | British Columbia | V8R 6T9 | Canada |
| Hamilton District Urology Associaton | Hamilton | Ontario | L8N 1T8 | Canada |
| Centre for Advanced Urological Research at Queen's University | Kingston | Ontario | K7L 3J7 | Canada |
| Urology Clinic & Prostate Centre, St. Joseph's Hospital, St. Joseph's Health Care London | London | Ontario | N6A 4V2 | Canada |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided