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CTRI Number  CTRI/2024/05/067809 [Registered on: 22/05/2024] Trial Registered Prospectively
Last Modified On: 24/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   The clinical investigation study of steerable ureteral catheter system for the treatment and removal of urinary stones (kidney stones, fragments, and dust). 
Scientific Title of Study   A prospective study to evaluate the safety and effectiveness of steerable Ureteroscopic Renal Evacuation (SURE) using CVAC® Set. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
IMP/MD/2024/000454 [Form MD-17], Date 25 APR 2024   DCGI 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahesh Desai 
Designation  Managing Trustee/Consultant, Dept of Urology 
Affiliation  Muljibhai Patel Society for Research in Nephro-Urology 
Address  Muljibhai Patel, Society for Research in Nepro-Urology c/o Muljibhai Patel Urological Hospital, Dr. Virendra Desai Road, Nadiad

Kheda
GUJARAT
387001
India 
Phone  02682520323  
Fax    
Email  mrdesai@mpuh.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Niramya Pathak 
Designation  Consultant Neurology / Sub investigator 
Affiliation  Muljibhai Patel Society for Research in Nephro-Urology 
Address  Muljibhai Patel, Society for Research in Nepro-Urology c/o Muljibhai Patel Urological Hospital, Dr. Virendra Desai Road, Nadiad

Kheda
GUJARAT
387001
India 
Phone  02682520323  
Fax    
Email  niramya.pathak@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ajay Gangoli 
Designation  Medical Director 
Affiliation  Muljibhai Patel Society for Research in Nephro-Urology 
Address  Muljibhai Patel, Society for Research in Nepro-Urology c/o Muljibhai Patel Urological Hospital, Dr. Virendra Desai Road, Nadiad

Kheda
GUJARAT
387001
India 
Phone  02682520323  
Fax    
Email  ajay.gangoli@mpuh.org  
 
Source of Monetary or Material Support  
Calyxo, Inc. 
 
Primary Sponsor  
Name  Calyxo, Inc. 
Address  4473 Willow Road Suite 100 Pleasanton, CA 94588, USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Veeda Clinical Research Limited  Shivalik Plaza-A, 2nd Floor, Opp Ahmedabad Management Association (I.I.M Road), Ambawadi, Ahmedabad, Gujarat (India) - 380015. Telephone No.: 7227022924 FAX: 7227022924 Email: RegulatoryAffairs@veedacr.com  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mahesh Desai  Muljibhai Patel Urological Hospital  Department: Urology, Ground floor, Muljibhai Patel Society For Research In Nephro-Urology, c/o Muljibhai Patel Urological Hospital, Dr. Virendra Desai Road, Nadiad,387001.
Kheda
GUJARAT 		 02682520323

mrdesai@mpuh.org 
 
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  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter, (2) ICD-10 Condition: N288||Other specified disorders of kidney and ureter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  steerable ureteral catheter [CVAC Aspiration System]  Total duration of intervention is 4 Weeks. Flexible steerable ureteral catheter employing ureteroscopy with irrigation and vacuum capability. It is comprised of well-characterized biocompatible materials commonly used in urinary and ureteral catheters. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. ≥ 18 years of age;
2. Candidate for ureteroscopy with laser lithotripsy;
3. Total renal stone burden of 7 mm - 30 mm as measured by the sum of the longest dimension from the axial, coronal or sagittal view (whichever is longest) of each stone on CT within 90 days before the index procedure;
4. Be willing and able to return for and respond to all study-related follow up procedures; and,
5. Have been informed of the nature of the study and have agreed to the IRB approved informed consent form (ICF) 
 
ExclusionCriteria 
Details  1. Significant morbidities that in the opinion of the Investigator, could represent an increased perioperative risk for the subject;
2. Challenging renal anatomy that does not allow for initiation of SURE;
3. Ipsilateral partial nephrectomy within 6 months prior to index procedure;
4. History of ipsilateral ureteral reimplantation or ureteral reconstruction;
5. Simple or radical prostatectomy within 6 months prior to index procedure;
6. History of urinary diversion;
7. Ureteral ipsilateral stricture, untreated;
8. Ureteral stricture, untreated (not to include “tight” ureter);
9. Ipsilateral impacted ureteral stone (not to include proximal ureter or ureteropelvic junction “UPJ” stones);
10. Medullary sponge kidney;
11. Renal insufficiency requiring dialysis at the time of screening;
12. Bleeding diathesis (anticoagulants that cannot be discontinued); and
13.Any subjects with intraoperative complications, i.e., ureteral trauma, prior to introduction of CVAC®. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary efficacy endpoint is the stone clearance, defined as percent reduction in stone volume. At post-op day (POD) 1 on NCCT by independent reviewer.  baseline, 1 day & 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary endpoints are listed below.
1. Stone clearance at post-op day (POD) 30
2. Stone Free Rate (SFR) at post-op day (POD) 1 and (POD) 30
3. Residual stone volume at post-op day (POD) 1 and post-op day (POD) 30 		 baseline and post-op day (POD) 1 and POD 30 non-contrast CT (NCCT) 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/09/2024 
Date of Study Completion (India) 31/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  		 Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   The CVAC® Set is comprised of the single use CVAC® Aspiration System and the reusable CVAC® Image Processor. The CVAC Aspiration System is a sterile, single use, steerable ureteral catheter system with integrated vision, irrigation and aspiration and is intended to establish a conduit during endoscopic urological procedures for the treatment and removal of urinary stones (kidney stones, fragments, and dust). It employs flexible ureteroscopy within the urinary tract for endoscopic examination of the urinary tract and the interior of the kidney, and to irrigate and apply suction to remove stone and dust fragments in the renal pelvis and calyces during the endoscopic urological kidney stone removal procedure. The CVAC Image Processor is a video processor that is used for clinical image processing. The CVAC Aspiration System is compatible with currently marketed accessories for stone removal, including single-use laser fibers and stone baskets, which are inserted and used in the working channel. The CVAC Image Processor generates a video signal compatible with standard external monitors. The CVAC Set is designed to perform standard ureteroscopy and to remove stone fragments and stone dust using the same device.
 
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