MedDataX Logo

AQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia

NCT ID: NCT03167294

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-14

Study Completion Date

2017-04-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Single-arm prospective, interventional clinical trial. Results will be compared to a historical control in the treatment of benign prostatic hyperplasia

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Benign Prostatic Hyperplasia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Aquablation AQUABEAM BPH LUTS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single Arm

AquaBeam System for resection and removal of prostatic tissue in males suffering from BPH

Group Type OTHER

AquaBeam System

Intervention Type DEVICE

Aquablation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AquaBeam System

Aquablation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male
* 50 - 80 years
* Moderate to severe BPH
* Subjects who have failed standard medical therapy

Exclusion Criteria

* Size and width of prostate
* Medical condition or co-morbidities where BPH intervention would be contraindicated
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

PROCEPT BioRobotics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ravindra Sabnis

Role: PRINCIPAL_INVESTIGATOR

Chairman, department of Urology Muljibhai Patel Urological Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Muljibhai Patel Urological Hospital

Nadiād, Gujarat, India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States India

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TP0032

Identifier Type: -

Identifier Source: org_study_id