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Spots Global Cancer Trial Database for Rezum FIM Optimization Study

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Trial Identification

Brief Title: Rezum FIM Optimization Study

Official Title: Rezum First in Man Feasibility Study for the Treatment of BPH With the Rezum System

Study ID: NCT02940392

Interventions

Rezum System

Study Description

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.

Keywords

Eligibility

Minimum Age: 45 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Clinica Canela, La Romana, , Dominican Republic

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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