| CTRI Number |
CTRI/2014/12/005238 [Registered on: 02/12/2014] Trial Registered Prospectively |
| Last Modified On: |
20/01/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A research project to study the safety and performance of device known as AQUABEAM for the treatment of Benign Prostatic Hyperplasia (non cancerous enlargement of Prostate) |
|
Scientific Title of Study
|
PROCEPT AQUABEAM Study for the treatment of Benign Prostatic Hyperplasia (ABS) |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| TP0032, Version Number: Revision B, dated 22 Sep 2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravindra Sabnis |
| Designation |
Chairman |
| Affiliation |
Muljibhai Patel Urological Hospital |
| Address |
Department of Urology
Muljibhai Patel Urological Hospital,
Dr. Virendra Desai Road, Nadiad - 387001,
Gujarat, India
Kheda
GUJARAT
387001
India |
| Phone |
91-9426422002 |
| Fax |
|
| Email |
rbsabnis@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sonika Newar |
| Designation |
Medical Monitor |
| Affiliation |
JSS Medical Research India Private Limited |
| Address |
JSS Medical Research India Private Limited
6th Floor, Vatika Mindscapes
Tower B, Plot 12/2, Sector 27D, Faridabad- 121003 (Haryana) India
Faridabad
HARYANA
121003
India |
| Phone |
91-8800799887 |
| Fax |
91-129-6613510 |
| Email |
sonika.newar@jssresearch.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shariq Anwar |
| Designation |
Head Operations |
| Affiliation |
JSS Medical Research India Private Limited |
| Address |
JSS Medical Research India Private Limited
6th Floor, Vatika Mindscapes
Tower B, Plot 12/2, Sector 27D, Faridabad- 121003 (Haryana) India
Faridabad
HARYANA
121003
India |
| Phone |
91-9810979215 |
| Fax |
91-129-6613510 |
| Email |
shariq.anwar@jssresearch.com |
|
|
Source of Monetary or Material Support
|
| PROCEPT BioRobotics Corporation |
|
|
Primary Sponsor
|
| Name |
PROCEPT BioRobotics Corporation |
| Address |
900 Island Drive, Suite 10
Redwood City, CA 94065,USA
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| JSS Medical Research India Private Limited |
6th Floor, Vatika Mindscapes
Tower B, Plot 12/2, Sector 27D
Faridabad - 121003 (Haryana) India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravindra Sabnis |
Muljibhai Patel Urological Hospital |
Department of Urology, Ground Floor
Dr. Virendra Desai Road, Nadiad - 387001,
Gujarat, India
Kheda
GUJARAT |
91-9426422002
rbsabnis@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Muljibhai Patel Society for Research in Nephro-Urology Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Benign Prostatic Hyperplasia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable. |
Not Applicable. |
| Intervention |
PROCEPT AQUABEAM® System |
The AQUABEAM® System is intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
The target patient population is patients with symptomatic BPH who have not responded adequately to standard medical therapy.
Inclusion Criteria
a) Male
b) Age 50 - 80 years
c) Prostate size ≥ 25 g and ≤ 120 g
d) IPSS score > 12
e) Qmax ≤ 15ml/s
f) History of inadequate response,contraindication or refusal to medical
therapy
g) Patient is mentally capable and willingto sign a study-specific informed
consent form
h) Patient is willing and able to complywith all study requirements
i) Schaffer scale ≥Grade 2
|
|
| ExclusionCriteria |
| Details |
a) History of, current or suspected prostate/bladder cancer
b) Elevated PSA (age 50-70 PSA ≥4; age 70-80 PSA
≥6.5) unless negative biopsy within last 3 months or positive biopsy
c) Neurogenic bladder
d) Prostatitis treated with antibiotics within 1 year of enrollment
e) Current Urethral stricture, meatal stenosis, or bladder neck contracture
f) Previous prostate surgery
g) Significant Renal impairment
h) Active infection, including urinary tract infection
i) Patients on anticoagulants (if medication cannot be stopped before and after procedure) or known coagulopathy
j) Gross haematuria
k) Known allergy to device materials
l) Any severe illness that would prevent complete study participation or confound study results
m) Serious concurrent medical conditions such as heart disease (e.g., myocardial infarction within 30 days, congestive heart failure – NYHA Class IV), pulmonary disease or uncontrolled diabetes.
n) Participants using immune-suppressants including corticosteroids; unable to withhold non-steroidal anti-inflammatory agents(NSAIDs, including
aspirin) for 14 days prior to treatment; Known illicit substance abuse
o) Dementia or psychiatric condition that prevents the participant from completing required follow up
p) Contraindication to general anesthesia
q) Participating in another investigational study that could affect responses to the study device
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Device performance outcome:
• Completion of the intended surgical procedure
Primary Safety outcome:
• Peri-operative complication rate.
|
On the day of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Change from baseline in International Prostate System Score, International Index of Erectile Function. |
From baseline to study completion.
Also includes one unscheduled visit: Baseline and 12 months
|
| • Change from baseline in peak urinary flow rate, post-void residual volume and PDet@Qmax (Schaffer grade) |
Baseline and 6 months. |
Additional outcomes include:
• Proportion of subjects and period of Foley catheter placement postoperatively: Baseline and 1 week
• Change in prostate volume at 6 months
• Additional exploratory analysis may be performed as necessary: Baseline and 12 months
|
Baseline and 1 week, 6 months, Baseline and 12 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
14/12/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
|
This is Single-arm,
prospective, interventional clinical trial. 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). Each subject is
followed for 12 months (1 year) postoperatively. Enrollment is expected to
take up to 3 months. Total study duration is 27 months. The target patient
population is patients with symptomatic BPH who have not responded adequately
to standard medical therapy. |
|