To Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China

NCT04823221 | Completed Results FDA Device

• 1 other identifier: U0719
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

A real world study to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China Rezūm RWS study

Conditions

Benign Prostatic Hyperplasia (BPH)

Outcome Measures

Primary Outcomes (2)

• International Prostate Symptom Score (IPSS) Change From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure.

  International prostate symptom score (IPSS) is a questionnaire used to indicate the severity of LUTS symptoms, There are 7 questions relating to different symptoms subjects be experiencing. 7 questions about patients' urinating include Incomplete emptying, Frequency, Intermittency, Urgency, Weak stream, Straining and Nocturia, every question have 0-5 scores according to Prostate Symptom, the higher score mean patient have more severe the symptoms. IPSS total score: the minimum score is 0 and maximum score are 35. IPSS total 0-7 scores are mild symptoms, IPSS total 8-19 scores are moderate symptoms and IPSS total 20-35 scores are severe symptoms The change was the value at the baseline minus the value at last follow-up date, anywhere between month 3 - month 6 minus

  from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure

• Device Related Serious Complications From Rezūm Procedure to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure.

  Composite device related serious complications for this endpoint are defined as: 1. Device perforation of the rectum or GI tract; 2. Device related formation of fistula between the rectum and urethra; 3. De novo severe urinary retention lasting more than 21 consecutive days post treatment.

  from Rezūm procedure to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure.

Secondary Outcomes (7)

• Rezūm Procedure Time

  During Rezūm procedure

• Length of Catheterization

  1 month post Rezum procedure

• The Change of Peak Flow Rate (Qmax) From Baseline to the Last Follow-up Date, Anywhere Between Month 3 - Month 6 Post Rezūm Procedure.

  from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure.

• Post Void Residual Urine Volume (PVR）

  from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezūm procedure.

• Quality of Life (Qol)

  from baseline to the last follow-up date, anywhere between month 3 - month 6 post Rezum procedure

Study Arms (1)

Rezūm system

The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra.

Device: Rezūm System

Interventions

Rezūm System DEVICE

The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra.

Rezūm system

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 30 subjects who were diagnosed as BPH and treated with Rezūm system will be collected to get 22 treated subjects with valid data.

You may qualify if:

• The subjects will provide written informed consent form and agree to data collection.
• The subjects who were diagnosed as BPH and treated by Rezūm procedure in Hainan medical pilot zone will be enrolled in this study.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Boao Yiling Life Care Center

Boao, Hainan, 571437, China

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Ming Liu
• Organization: Boao Yiling Life Care Center

liuming9876@yeah.net

139 1103 6970

Study Officials

• Ming Liu, Dr

  Boao Yiling Life Care Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 30, 2021
• Study Start: July 10, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: March 2, 2022
• Results First Posted: February 17, 2022

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)