Rezum FIM Optimization Study

NCT ID: NCT02940392

Last Updated: 2021-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-19
• Study Completion Date: 2017-05-19

Brief Summary

Evaluate the effect of the NxThera BPH Rezum System on prostate tissue in subjects suffering from LUTS symptoms secondary to benign prostatic hyperplasia (BPH).

Detailed Description

Subjects with BPH symptoms were treated with the Rezum device with a range of thermal energies (as measured by calorie output) to optimize the setting for maximum lesion size with minimal intra and post-procedure discomfort. Lesion size and ablated tissue resorption rate was followed post-procedure at 1 week, 1 month, 3 months, and 6 months.

Conditions

Benign Prostatic Hyperplasia; Adenoma, Prostatic; Prostatic Adenoma; Prostatic Hyperplasia, Benign; Prostatic Hypertrophy; Prostatic Hypertrophy, Benign; Rezum

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rezum Treatment

Patients will receive the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia.

Group Type: EXPERIMENTAL

Rezum System

Intervention Type: DEVICE

The Rezūm System is designed to treat patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death.

The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.

Interventions

Rezum System

The Rezūm System is designed to treat patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death.

The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.

Intervention Type: DEVICE

Other Intervention Names

Rezum Procedure; Rezum; Water Vapor Ablation; Rezum Delivery Device; Rezum Generator

Eligibility Criteria

Inclusion Criteria

1. Male subjects > 45 years of age who have symptomatic / obstructive symptoms secondary to BPH requiring invasive intervention.

2. IPSS score of ≥ 15.

3. Qmax: Peak flow rate ≤ 15 ml/sec.

4. Post-void residual (PVR) < 300 ml.

5. Prostate transverse diameter > 30 mm.

6. Prostate volume between 20 to 120 gm.

7. Voided volume ≥ 125 ml.

8. Subject able to complete the study protocol in the opinion of the Principal Investigator.

9. Subject must be willing to undergo the procedure without anesthesia.

Exclusion Criteria

1. History of any illness or surgery that in the opinion of the Principal Investigator may confound the results of the study.

2. Presence of a penile implant.

3. Any prior minimally invasive intervention (e.g. TUNA,Laser, Microwave) or surgical intervention for the symptoms of BPH.

4. Currently enrolled in another clinical trial.

5. Confirmed or suspected malignancy of prostate or bladder.

6. Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease.

7. Previous pelvic irradiation or radical pelvic surgery.

8. Documented active urinary tract infection by culture or bacterial prostatitis within last year documented by culture (UTI is defined as >100,000 colonies per ml urine from midstream clean catch or catheterization specimen).

9. Neurogenic bladder or sphincter abnormalities.

10. Urethral strictures, bladder neck contracture or muscle spasms.

11. Bleeding disorder (note that use of anti-platelet medication is not an exclusion criterion).

12. Subjects who are interested in maintaining fertility.

13. Use of concomitant (or recent) medications to include the following:

1. Beta blockers, antihistamines, anticonvulsants, and antispasmodics within 1 week of treatment, unless there is documented evidence of stable dosing for last 6 months (e.g., no dose changes).

2. Alpha blockers, antidepressants, anticholinergics, androgens, or gonadotropin-releasing hormonal analogs within 2 weeks of treatment.

3. 5-alpha reductase inhibitor within the last 6 months

14. Subject is unable or unwilling to go through a "washout" period for the above medications prior to treatment.

15. Subject has chronic urinary retention.

16. Significant urge incontinence.

17. Poor detrusor muscle function.

18. Neurological disorders which might affect bladder or sphincter function.

19. Bladder stones.

20. Renal impairment.

21. In the opinion of the Principal Investigator, subject will not be able to adequately tolerate a rigid cystoscopy-type procedure.

22. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the required follow-up requirements.

23. Any cognitive disorder that interferes with or precludes a subject from directly and accurately communicating with the Principal Investigator regarding the study.

24. Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e., claudication of the buttocks or perineum).

25. Biopsy of the prostate within 30 days prior to the Rezūm procedure.

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinica Canela

La Romana, , Dominican Republic

Countries

Dominican Republic

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1633-001

Identifier Type: -

Identifier Source: org_study_id