- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03125889
Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia II (AHA II)
November 10, 2017 updated by: PROCEPT BioRobotics
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gujarat
-
Nadiad, Gujarat, India, 387001
- Muljibhai Patel Urological Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male
- BPH symptoms
Exclusion Criteria:
- Serious concurrent medical conditions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Arm
Subjects will receive treatment with the AquaBeam System to remove prostatic tissue.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Completion of the intended surgical procedure with adequate hemostasis
Time Frame: 7 days post-op
|
7 days post-op
|
Proportion of subjects who return to the OR for bleeding treatment or requires transfusion
Time Frame: 7 days post-op
|
7 days post-op
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 10, 2017
Primary Completion (Actual)
April 18, 2017
Study Completion (Actual)
July 7, 2017
Study Registration Dates
First Submitted
March 14, 2017
First Submitted That Met QC Criteria
April 19, 2017
First Posted (Actual)
April 24, 2017
Study Record Updates
Last Update Posted (Actual)
November 14, 2017
Last Update Submitted That Met QC Criteria
November 10, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TP0131
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Benign Prostatic Hyperplasia
-
St. Joseph's Healthcare HamiltonOntario Ministry of Health and Long Term CareCompletedBenign Prostatic HyperplasiaCanada
-
San Carlo di Nancy HospitalElesta S.R.L.CompletedBenign Prostatic Hyperplasia | Benign Prostatic Hypertrophy | Benign Prostatic Hypertrophy With Outflow Obstruction | Prostate HyperplasiaItaly
-
GlaxoSmithKlineCompletedBenign Prostatic Hyperplasia
-
Catholic University of the Sacred HeartCompletedBenign Prostatic Hyperplasia (BPH) | Benign Prostatic Enlargement (BPE)Italy
-
Boston Scientific CorporationCompletedProstatic Hyperplasia | Benign Prostatic Hyperplasia | Prostatic Hyperplasia, Benign | Prostatic Hypertrophy | Prostatic Hypertrophy, Benign | Adenoma, Prostatic | Prostatic Adenoma | RezumDominican Republic, Czechia, Sweden
-
Boston Scientific CorporationCompletedBenign Prostatic Hyperplasia | Prostatic Hyperplasia, Benign | Prostatic Hypertrophy | Prostatic Hypertrophy, Benign | Adenoma, Prostatic | Prostatic Adenoma | RezumDominican Republic
-
IMBiotechnologies Ltd.CompletedBenign Prostatic Hyperplasia | Benign Prostatic HypertrophyCanada
-
IRCCS Policlinico S. MatteoCompletedBenign Prostatic Hyperplasia | Benign Prostatic Hypertrophy With Outflow ObstructionItaly
-
American Medical SystemsCompletedBenign Prostatic Hyperplasia | BPH | Benign Prostatic Hypertrophy | Prostate Disease
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Not yet recruitingLower Urinary Tract Symptoms | Benign Prostate Hyperplasia | Benign Prostatic Hypertrophy With Outflow Obstruction
Clinical Trials on AquaBeam System
-
PROCEPT BioRoboticsCompletedBenign Prostatic HyperplasiaIndia
-
PROCEPT BioRoboticsCompletedBenign Prostatic Hyperplasia (BPH)France
-
PROCEPT BioRoboticsCompletedBenign Prostatic HyperplasiaIndia
-
Centre hospitalier de l'Université de Montréal...PROCEPT BioRoboticsRecruitingLower Urinary Tract Symptoms | Benign Prostatic HyperplasiaCanada
-
PROCEPT BioRoboticsCompletedBenign Prostatic Hyperplasia (BPH)United States, Australia, United Kingdom, New Zealand
-
PROCEPT BioRoboticsCompletedBenign Prostatic HyperplasiaIndia
-
ResMedCompleted
-
Federal University of São PauloCompletedAdverse Reaction to Systemic AgentsBrazil
-
KineticureCompletedOsteoarthritis | Knee PainUnited States