AQUABEAM India Study for the Treatment of Benign Prostati... | NCT03167294

Studies
AQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia

NCT03167294

Sponsor

PROCEPT BioRobotics

Status

Completed

Last Update Posted

Nov 17, 2017Actual

Enrollment

47Actual

Phase

Not Applicable

Conditions

Benign Prostatic Hyperplasia

Interventions

AquaBeam System

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 14, 2014Actual

Primary Completion Date

Jun 30, 2016Actual

Completion Date

Apr 27, 2017Actual

First Submitted Date

Dec 11, 2014

First Submission Date that Met QC Criteria

May 24, 2017

First Posted Date

May 25, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2017

Last Update Posted Date

Nov 17, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Other	AquaBeam System for resection and removal of prostatic tissue in males suffering from BPH	Device: AquaBeam System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AquaBeam System	Device	Aquablation	Single Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Device Performance Endpoint	The primary device performance endpoint is completion of the intended surgical procedure.	6 months
Primary Safety Endpoint of the study is the perioperative complication rate.	The primary safety endpoint of the study is the perioperative complication rate	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ravindra Sabnis	Chairman, department of Urology Muljibhai Patel Urological Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Muljibhai Patel Urological Hospital		Nadiād	Gujarat	387001	India

Condition Browse Module

MeSH Terms

ID	Term
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided