Trial Outcomes & Findings for Occlusion Balloon vs. 5FR Ureteral Catheter (NCT NCT06798753)
NCT ID: NCT06798753
Last Updated: 2026-04-20
Results Overview
Endoscopic identification of ureteral stone fragments will be used to compare rate of ureteral stone fragments upon completion of PCNL while using OBC versus 5FR-UC.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
108 participants
Primary outcome timeframe
During procedure, up to 5 hours
Results posted on
2026-04-20
Participant Flow
Participant milestones
| Measure |
Occlusion Balloon Catheter
The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.
Occlusion Balloon Catheter: The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.
|
5FR Ureteral Catheter
The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.
5FR Ureteral Catheter: The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
53
|
|
Overall Study
COMPLETED
|
51
|
48
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Occlusion Balloon Catheter
The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.
Occlusion Balloon Catheter: The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.
|
5FR Ureteral Catheter
The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.
5FR Ureteral Catheter: The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.
|
|---|---|---|
|
Overall Study
intraoperative findings
|
4
|
5
|
Baseline Characteristics
Occlusion Balloon vs. 5FR Ureteral Catheter
Baseline characteristics by cohort
| Measure |
5FR Ureteral Catheter
n=48 Participants
The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.
5FR Ureteral Catheter: The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.
|
Total
n=99 Participants
Total of all reporting groups
|
Occlusion Balloon Catheter
n=51 Participants
The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.
Occlusion Balloon Catheter: The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=22 Participants
|
59 years
n=151 Participants
|
60 years
n=129 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=22 Participants
|
36 Participants
n=151 Participants
|
20 Participants
n=129 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=22 Participants
|
63 Participants
n=151 Participants
|
31 Participants
n=129 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=22 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=22 Participants
|
8 Participants
n=151 Participants
|
6 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=22 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=22 Participants
|
9 Participants
n=151 Participants
|
5 Participants
n=129 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=22 Participants
|
81 Participants
n=151 Participants
|
40 Participants
n=129 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=22 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=22 Participants
|
1 Participants
n=151 Participants
|
0 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=22 Participants
|
16 Participants
n=151 Participants
|
5 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=22 Participants
|
83 Participants
n=151 Participants
|
46 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=22 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=129 Participants
|
|
eGFR
|
91 mL/min/1.73m^2
n=22 Participants
|
89 mL/min/1.73m^2
n=151 Participants
|
84 mL/min/1.73m^2
n=129 Participants
|
|
stone size
|
20 mm
n=22 Participants
|
20 mm
n=151 Participants
|
21 mm
n=129 Participants
|
|
Side of body
Right side
|
15 Participants
n=22 Participants
|
34 Participants
n=151 Participants
|
19 Participants
n=129 Participants
|
|
Side of body
Left side
|
33 Participants
n=22 Participants
|
65 Participants
n=151 Participants
|
32 Participants
n=129 Participants
|
PRIMARY outcome
Timeframe: During procedure, up to 5 hoursEndoscopic identification of ureteral stone fragments will be used to compare rate of ureteral stone fragments upon completion of PCNL while using OBC versus 5FR-UC.
Outcome measures
| Measure |
Occlusion Balloon Catheter
n=51 Participants
The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.
Occlusion Balloon Catheter: The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.
|
5FR Ureteral Catheter
n=48 Participants
The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.
5FR Ureteral Catheter: The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.
|
|---|---|---|
|
Number of Participants With Ureteral Stone Fragments Identified Endoscopically
|
2 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: During procedure, up to 5 hoursLength of procedure is a common procedural outcome of endourologic procedures.
Outcome measures
| Measure |
Occlusion Balloon Catheter
n=51 Participants
The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.
Occlusion Balloon Catheter: The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.
|
5FR Ureteral Catheter
n=48 Participants
The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.
5FR Ureteral Catheter: The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.
|
|---|---|---|
|
Length of Procedure
|
100 minutes
Interval 72.0 to 132.0
|
90 minutes
Interval 68.0 to 125.0
|
SECONDARY outcome
Timeframe: During procedure, up to 5 hoursNumber of participants with intraoperative complications, a common procedural outcome of endourologic procedures
Outcome measures
| Measure |
Occlusion Balloon Catheter
n=51 Participants
The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.
Occlusion Balloon Catheter: The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.
|
5FR Ureteral Catheter
n=48 Participants
The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.
5FR Ureteral Catheter: The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.
|
|---|---|---|
|
Number of Participants With Intraoperative Complications
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: during procedure, up to 5 hoursNumber of participants with stent placement during procedure
Outcome measures
| Measure |
Occlusion Balloon Catheter
n=51 Participants
The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.
Occlusion Balloon Catheter: The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.
|
5FR Ureteral Catheter
n=48 Participants
The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.
5FR Ureteral Catheter: The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.
|
|---|---|---|
|
Number of Participants With Stent Placement
|
22 Participants
|
23 Participants
|
Adverse Events
Occlusion Balloon Catheter
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
5FR Ureteral Catheter
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mantu Gupta
Icahn School of Medicine at Mount Sinai
Phone: 212-241-1272
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place