Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (US)

NCT ID: NCT01896973

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-12-31

Brief Summary

The HistoSonics' Histotripsy BPH Device, the Vortx Rx, is a portable ultrasound therapy device. The purpose of this study is to assess and monitor the performance of the Vortx Rx for initial safety and efficacy for the treatment of Benign Prostatic Hyperplasia.

Detailed Description

Prospective, single-arm study

Conditions

Benign Prostatic Hyperplasia (BPH)

Study Design

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

Study Groups

Vortx Rx - Histotripsy BPH Device

The Vortx Rx is a portable ultrasound therapy device system that is intended for the treatment of BPH by using very intense, low duty-cycle ultrasound pulses to debulk prostatic tissue.

Group Type: EXPERIMENTAL

Vortx Rx - Histotripsy BPH Device

Intervention Type: DEVICE

Non-invasive histotripsy treatment/therapy to be delivered by the surgeon using very low duty cycle ultrasound pulses from outside the patient's body. These pulses form a bubble cloud at the end of the focal area within the prostate which mechanically breaks up the cellular structure of the soft tissue. During treatment, a surgeon is able to direct the bubble cloud throughout the targeted volume using controls located on the device console and using the real-time ultrasound for visualization feedback and control of the bubble cloud location.

Interventions

Vortx Rx - Histotripsy BPH Device

Non-invasive histotripsy treatment/therapy to be delivered by the surgeon using very low duty cycle ultrasound pulses from outside the patient's body. These pulses form a bubble cloud at the end of the focal area within the prostate which mechanically breaks up the cellular structure of the soft tissue. During treatment, a surgeon is able to direct the bubble cloud throughout the targeted volume using controls located on the device console and using the real-time ultrasound for visualization feedback and control of the bubble cloud location.

Intervention Type: DEVICE

Other Intervention Names

HistoSonics Histotripsy BPH device; Vortx Rx

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of BPH and eligible for endoscopic BPH surgery including TURP, PVP, electrovaporization.

2. Prostate volumes 30 - 80 gm based on transrectal ultrasound

3. Men ≥ 50 years of age

4. IPSS symptom score ≥ 13 and IPSS bother score > 2 (see Appendix B for IPSS questionnaire)

5. Baseline peak flow rate Qmax ≤ 15 cc/s with voided volume at least 125 cc

Exclusion Criteria

1. History of prostate or bladder cancer, pelvic radiation, untreated bladder stones, urethral strictures/bladder neck contracture (BNC), renal insufficiency (i.e. creatinine > 1.4)

2. Neurogenic bladder, Parkinson's disease

3. Prior treatment for urinary incontinence

4. Micturition frequency AND urgency. Micturition frequency defined as > 8 micturitions per 24 hours as assessed by a thorough subject history including the question: "On average, how many times do you void during a 24 hour period? // < 4, 5-7, 8 or more." Urgency defined as an uncontrollable urge to void that occurs > 3 per 24 hours as assessed through the subject history/question: "On average, how many times a day do you have an uncontrollable urgency to void? // 0, 1-2, 3 or more?"

5. Intravesical prostate lobe protrusion > 1 cm on TRUS. Note: this is distinct from lateral lobes protruding up to the bladder such as an intravesical protrusion without median lobe

6. Active UTI (i.e. must have a screening urinalysis without signs of infection or a negative urine culture)

7. PVR > 250 at time of enrollment or catheter dependent bladder drainage

8. History of chronic prostatitis within the last 5 years

9. Not able to temporarily discontinue aspirin, Coumadin, Plavix and any other anticoagulant at least seven days prior to the time of treatment

10. History of known bleeding disorders (e.g. von Willebrand disease [VWD]) and subjects determined to have a bleeding disorder by prothrombin time (PT) and partial thromboplastin time (PTT) tests.

11. Prior BPH prostate procedures (e.g. TUMT, TUNA, water induced thermotherapy [WIT], TURP, PVP)

12. Men with confirmed or suspected malignancy of the prostate based on a digital rectal exam (DRE), prostate biopsy or PSA > 10 ng/mL. Men with free PSA < 25% and PSA between 2.5 and 10 ng/mL may only be enrolled after a negative biopsy. If a prior prostate biopsy was performed within one year of enrollment and was negative for cancer, repeat biopsy is not required if in the investigator's judgment there is no clinical evidence to support biopsy reassessment. If a biopsy is required, the subject shall have a six-week waiting period between the biopsy and histotripsy treatment, if he is otherwise deemed eligible to participate in the study.

13. Men interested in future fertility

14. Declines or unable to provide informed consent

15. Non-English-speaker

16. Life expectancy estimated to be less than one year

17. Unable or unwilling to complete all required questionnaires and follow-up assessments

18. In the opinion of the investigator, it is not in the subject's best interest to participate in the study.

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

HistoSonics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timonthy Schuster, MD

Role: PRINCIPAL_INVESTIGATOR

ProMedica Parkway Surgery Center

John Wei, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Univerisity of Michigan

Ann Arbor, Michigan, United States

ProMedica Parkway Surgery Center

Toledo, Ohio, United States

Countries

United States

Other Identifiers

01.CP.0.1

Identifier Type: -

Identifier Source: org_study_id