Back to resultsAcute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia II (AHA II)
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
- BPH symptoms
Exclusion Criteria:
- Serious concurrent medical conditions
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 prostatic tissue.
Outcomes
Primary Outcome Measures
Completion of the intended surgical procedure with adequate hemostasis
Proportion of subjects who return to the OR for bleeding treatment or requires transfusion
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03125889
Brief Title
Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia II
Acronym
AHA II
Official Title
Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia II
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
April 18, 2017 (Actual)
Study Completion Date
July 7, 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
Product Manufactured in and Exported from the U.S.
Yes
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 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 LUTS due to BPH. The AQUABEAM System is intended for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS).The primary objective of this study is to evaluate the safety and performance of obtaining hemostasis with catheters following prostate resection using AQUABEAM for the treatment of LUTS resulting from BPH. Up to 50 participants will be included in the trial at one clinical study site. All patients will be followed up for 30 days for safety assessment prior to study exit. The trial is a single-arm prospective, interventional clinical trial.
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
11 (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 prostatic tissue.
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 with adequate hemostasis
Time Frame
7 days post-op
Title
Proportion of subjects who return to the OR for bleeding treatment or requires transfusion
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
BPH symptoms
Exclusion Criteria:
Serious concurrent medical conditions
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 II
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