| CTRI Number |
CTRI/2026/01/101616 [Registered on: 20/01/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing a New Medical Device for Urinary Problems Caused by an Enlarged Prostate |
|
Scientific Title of Study
|
A Pilot Study of the ALPFA BPH PFA System in Men with Symptomatic Benign Prostatic Hyperplasia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CS 00001 Revision 1 issue date: 02DEC2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Balwant Kulkarni |
| Designation |
Principal Investigator |
| Affiliation |
Urokul Hospital |
| Address |
Plot No: 6t/2/L,11/1, Mumbai Pune Bypass Rd, Next to Bitwise Terratower, Mohan Nagar Co-Op Society, Baner, Pune, Maharashtra
-
Pune
MAHARASHTRA
411045
India |
| Phone |
9822024050 |
| Fax |
- |
| Email |
sanjaybkulkarni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Balwant Kulkarni |
| Designation |
Principal Investigator |
| Affiliation |
Urokul Hospital |
| Address |
Plot No: 6t/2/L,11/1, Mumbai Pune Bypass Rd, Next to Bitwise Terratower, Mohan Nagar Co-Op Society, Baner, Pune, Maharashtra
-
Pune
MAHARASHTRA
411045
India |
| Phone |
9822024050 |
| Fax |
- |
| Email |
sanjaybkulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meena Dalal |
| Designation |
CEO and Founder |
| Affiliation |
TrialGuna Private Limited |
| Address |
467, 1st Main, 4th Cross, Royal County Layout, JP Nagar, 8th Phase, 2nd Block, Bangalore, Karnataka-560083, India
-
Bangalore
KARNATAKA
560083
India |
| Phone |
9972636265 |
| Fax |
- |
| Email |
meena@trialguna.com |
|
|
Source of Monetary or Material Support
|
| ALPFA Medical, Inc.
3715 Haven Ave. Suite 100
Menlo Park, CA 94025-USA |
|
|
Primary Sponsor
|
| Name |
ALPFA Medical, Inc. |
| Address |
3715 Haven Ave. Suite 100
Menlo Park, CA 94025, USA |
| Type of Sponsor |
Other [Medical Equipment Manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Italy
Czech Republic
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Balwant Kulkarni |
Urokul Hospital |
Plot No: 6t/2/L,11/1, Mumbai Pune Bypass Rd,
Next to Bitwise Terratower
Mohan Nagar Co-Op Society, Baner
Pune
MAHARASHTRA |
9822024050
-
sanjaybkulkarni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Independent Ethics Committee- CIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
The ALPFA BPH PFA System is comprised of the following:
• ALPFA BPH PFA Catheter and Extension Cable
• ALPFA BPH PFA Generator System |
The intervention involves pulsed field ablation of prostate tissue using a transurethral catheter-based medical device. The catheter is introduced into the prostatic urethra through a flexible cystoscope. Based on the length of the prostatic urethra visualized during cystoscopy, two or three electrodes mounted on inflatable balloons are activated to deliver pulsed electrical energy to targeted prostate tissue.
The balloons are inflated with sterile normal saline to stabilize the catheter position and enable effective energy delivery. Energy delivery parameters, including the number of active electrodes and voltage settings, are selected and controlled by the operator using a touch screen-based generator interface. The procedure may involve catheter repositioning as required to ensure appropriate treatment coverage. Subjects undergo a single treatment session and are followed up according to the study protocol to assess safety and clinical outcomes. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1. Patients who are greater than equal to 45 years of age on the day of enrollment.
2. Patients who have failed to achieve satisfactory resolution of BPH symptoms using an
approved medication.
3. Patients with symptomatic BPH meeting all of the following criteria determined within
30 days preceding enrollment and after fulfilling the concomitant medication washout
period(s):
a. Symptom Score: a baseline IPSS score of 13 or greater |
|
| ExclusionCriteria |
| Details |
1. Medical conditions that would prevent participation in the study, interfere with
assessment or therapy, significantly raise the risk of study participation, or confound
data or its interpretation, including but not limited to:
a. Unstable cardiovascular disease including:
i. NYHA III/IV heart failure or LVEF less than 40%
ii. Uncontrolled arrhythmia
iii. Stroke, TIA, thromboembolic event, myocardial infarction, unstable angina, percutaneous coronary intervention or any cardiac surgery within 90 days of enrollment.
iv. Uncontrolled hypertension (SBP greater than 160 mmHg or DBP greater than 95 mmHg on two (2) BP measurements taken at least 3 minutes apart at baseline assessment).
b. Renal: Serum creatinine greater than 1.8 or any history of renal dialysis or renal transplant
c. Nonurologic cancer: Active malignancy (other than cutaneous basal cell or squamous cell carcinoma
d. Metabolic: clinically uncontrolled diabetes mellitus or a baseline HbA1c greater than equal to 8.0%, or clinically significant liver disease
e. Respiratory: Any lung disease involving abnormal blood gases or significant dyspnea
f. Infection: active systemic infection
g. Immunosuppression: Known immunosuppression, including but not limited to AIDS, immunosuppressive medication or current chemotherapy.
h. Coagulopathy: Diagnosed disorder of blood clotting or bleeding diathesis.
i. Transplant: History of any solid organ or hematologic transplant, or currently being evaluated for an organ transplant
j. Active substance abuse: active alcoholism or drug addiction
2. Urologic conditions that would prevent participation in the study, interfere with
assessment or therapy, significantly raise the risk of study participation, or confound
data or its interpretation, including but not limited to:
a. Previous operative intervention for BPH
b. Active urinary tract infection (may be treated and enrolled upon negative urine culture).
c. Incontinence: catheter dependent or had an episode of spontaneous urinary retention within 90 days of enrollment.
d. Prostatitis: a history of any prostatitis within 2 years of enrollment.
e. Cystolithiasis active within 90 days of enrollment
f. Neurogenic bladder: neurogenic or atonic bladder, including etiologies of
uncontrolled diabetes, Parkinson’s disease, multiple sclerosis, stroke/TIA or
polyneuropathy.
g. Anatomic abnormality: prior or current urethral stricture, meatal stenosis, bladder neck contracture or other urologic anatomic abnormalities that would interfere with planned treatment or confound subsequent assessment
(potentially an intra-procedural exclusion).
h. Implants: any urinary tract implants including stents, penile implants or artificial sphincters.
3. Bladder cancer: a history of treated bladder cancer of Stage T2 or higher, or a clinical
suspicion of bladder cancer.
4. Prostate cancer: a. Known or clinically suspected prostate cancer
b. A PSA value greater than 10 ng/ml
c. If PSA is greater than 2.5 ng/ml and less than equal to 10 ng/ml, prostate cancer must be ruled out via an MRI study
5. Concomitant medications: please see Section 6.2 for enrollment restrictions on medications for subject participation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Safety Endpoint: The safety endpoint for Phases Two and Three of this study is a Composite
Safety Endpoint (CSE) defined as the proportion of subjects with one or
more device- or procedure-related serious adverse events (SAEs) through
30 days post-procedure.
Primary Effectiveness Endpoint: All subjects will be assessed for symptomatic improvement using the
International Prostate Symptom Score (IPSS) instrument. The change from
baseline and the responder rate will be assessed at 90, 180 and 360 days. |
30, 90, 180, 360 days after the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in prostate symptom score, urinary flow parameters, prostate size, quality of life, and sexual function following treatment |
7 days, 30 days, 90 days, 180 days and 360 days post procedure |
|
|
Target Sample Size
|
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)
|
16/02/2026 |
| 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
|
Years="1"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, open-label, single-arm clinical study to evaluate the safety and feasibility of a catheter-based medical device for the treatment of benign prostatic hyperplasia in men with lower urinary tract symptoms. Male participants aged 45 years and above with persistent urinary symptoms despite prior medical therapy for benign prostatic hyperplasia will be screened for eligibility. After providing written informed consent, eligible participants will be enrolled in the study. Enrolled participants will undergo a single transurethral pulsed field ablation procedure performed under cystoscopic guidance. During the procedure, controlled electrical pulses are delivered through a catheter-based system to ablate targeted prostate tissue. Treatment settings and catheter positioning are determined by the investigator based on cystoscopic assessment of the prostatic urethra. Following the procedure, participants will be monitored for device- and procedure-related adverse events. Follow-up visits will be conducted at predefined intervals, including early and long-term assessments, up to 360 days after treatment. Study evaluations include assessment of safety outcomes, changes in urinary symptoms using validated symptom scores, urinary flow parameters, post-void residual urine volume, prostate-related laboratory parameters, quality of life measures, and sexual function. |