Back to resultsAcute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia (AHA)
Primary Purpose
Benign Prostatic Hyperplasia
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
AquaBeam System
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Image-guided, BPH, Aquablation, AQUABEAM, LUTS, Tissue resection, Robotics
Eligibility Criteria
Inclusion Criteria:
- Male age from 40 through 85 years with LUTS due to BPH
Exclusion Criteria:
- Any severe illness that would prevent complete study participation or confound study results
Sites / Locations
- Muljibhai Patel Urological Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
Subjects will receive treatment with the AquaBeam System to remove enlarged prostatic tissue. Following the aquablation intervention, a urinary catheter will be inserted to apply pressure on treated tissue for hemostasis.
Outcomes
Primary Outcome Measures
Completion of the intended surgical procedure
Proportion of subjects that require electrocautery or any other intervention post catheter removal.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03125863
Brief Title
Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia
Acronym
AHA
Official Title
Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 26, 2016 (Actual)
Primary Completion Date
September 3, 2016 (Actual)
Study Completion Date
July 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PROCEPT BioRobotics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A single-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis with commercially approved catheters following prostate resection using the AquaBeam for treatment of LUTS resulting from BPH.
Detailed Description
PROCEPT BioRobotics has developed the AquaBeam, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from Lower Urinary Tract Symptoms (LUTS) due to BPH. The AquaBeam System is intended for the resection and removal of prostate tissue in patients experiencing LUTS. The primary objective of the study is to evaluate the safety and performance of obtaining hemostasis with commercially approved catheters following prostate resection using the AquaBeam. The time frame of the study is 7 days. Up to 30 participants will be included in this single-site clinical trial. The trial is a single-arm prospective, interventional clinical study. Results will be analyzed to determine the safety and efficacy of commercially approved catheters for the achievement of acute hemostasis without the need for cauterization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Image-guided, BPH, Aquablation, AQUABEAM, LUTS, Tissue resection, Robotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Subjects will receive treatment with the AquaBeam System to remove enlarged prostatic tissue. Following the aquablation intervention, a urinary catheter will be inserted to apply pressure on treated tissue for hemostasis.
Intervention Type
Device
Intervention Name(s)
AquaBeam System
Intervention Description
The AquaBeam system delivers a high-velocity saline stream under precise electromechanical control and live ultrasound guidance to ablate prostatic glandular tissue without the production of heat. The physician uses ultrasound imaging to plan the treatment contour and depth to define the treatment region. The AquaBeam ablates the target tissue, adhering to the pre-defined treatment zone.
Primary Outcome Measure Information:
Title
Completion of the intended surgical procedure
Time Frame
7 days post-op
Title
Proportion of subjects that require electrocautery or any other intervention post catheter removal.
Time Frame
7 days post-op
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male age from 40 through 85 years with LUTS due to BPH
Exclusion Criteria:
Any severe illness that would prevent complete study participation or confound study results
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravindra Sabnis, MD
Organizational Affiliation
Muljibhai Patel Urological Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muljibhai Patel Urological Hospital
City
Nadiad
State/Province
Gujarat
ZIP/Postal Code
387001
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia
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