Trial Outcomes & Findings for Clinical Evaluation of BackStop in Patients Undergoing Ureteroscopic Lithotripsy (NCT NCT02122341)
NCT ID: NCT02122341
Last Updated: 2019-05-22
Results Overview
Prevention of retrograde stone migration (Yes/No)
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
At the time of surgery
Results posted on
2019-05-22
Participant Flow
Participant milestones
| Measure |
Experimental: BackStop
Patients randomized to the Experimental arm will receive the BackStop gel during their ureteroscopic lithotripsy to prevent retrograde migration of stones or stone fragments.
BackStop: BackStop™ is a FDA approved device. It is intended for use during ureteroscopic lithotripsy to prevent retrograde migration of stones and stone fragments. It is comprised of a solution of a thermosensitive polymer, a purified version of poloxamer 407 having been fractionated in saline. BackStop™, which is injected above the stone, is provided in sterile, pre-filled 2.5ml and 5ml syringes along with and a corresponding injector and a catheter (3F or 5F).
|
No Intervention: Control
Patients randomized to the control group will not use any devices to prevent retrograde migration of stones and stone fragments during their ureteroscopic lithotripsy.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
|
Overall Study
COMPLETED
|
17
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Evaluation of BackStop in Patients Undergoing Ureteroscopic Lithotripsy
Baseline characteristics by cohort
| Measure |
Experimental: Backstop
n=17 Participants
Patients randomized to the Experimental arm will receive the BackStop gel during their ureteroscopic lithotripsy to prevent retrograde migration of stones or stone fragments.
BackStop: BackStop™ is a FDA approved device. It is intended for use during ureteroscopic lithotripsy to prevent retrograde migration of stones and stone fragments. It is comprised of a solution of a thermosensitive polymer, a purified version of poloxamer 407 having been fractionated in saline. BackStop™, which is injected above the stone, is provided in sterile, pre-filled 2.5ml and 5ml syringes along with and a corresponding injector and a catheter (3F or 5F).
|
No Intervention: Control
n=18 Participants
Patients randomized to the control group will not use any devices to prevent retrograde migration of stones and stone fragments during their ureteroscopic lithotripsy.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
18 participants
n=7 Participants
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the time of surgeryPrevention of retrograde stone migration (Yes/No)
Outcome measures
| Measure |
Investigational: BackStop
n=17 Participants
Patients randomized to the Experimental arm will receive the BackStop gel during their ureteroscopic lithotripsy to prevent retrograde migration of stones or stone fragments.
BackStop: BackStop™ is a FDA approved device. It is intended for use during ureteroscopic lithotripsy to prevent retrograde migration of stones and stone fragments. It is comprised of a solution of a thermosensitive polymer, a purified version of poloxamer 407 having been fractionated in saline. BackStop™, which is injected above the stone, is provided in sterile, pre-filled 2.5ml and 5ml syringes along with and a corresponding injector and a catheter (3F or 5F).
|
No Intervention: Control
n=18 Participants
Patients randomized to the control group will not use any devices to prevent retrograde migration of stones and stone fragments during their ureteroscopic lithotripsy.
|
|---|---|---|
|
Rate of Prevention of Retrograde Stone or Stone Fragment Migration
Yes
|
14 Participants
|
11 Participants
|
|
Rate of Prevention of Retrograde Stone or Stone Fragment Migration
No
|
3 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Number of patients analyzed is inconsistent with numbers provided in participant flow module due to patients lost to follow up
Presence or absence of residual stone fragments at 2 month follow up after lithotripsy
Outcome measures
| Measure |
Investigational: BackStop
n=9 Participants
Patients randomized to the Experimental arm will receive the BackStop gel during their ureteroscopic lithotripsy to prevent retrograde migration of stones or stone fragments.
BackStop: BackStop™ is a FDA approved device. It is intended for use during ureteroscopic lithotripsy to prevent retrograde migration of stones and stone fragments. It is comprised of a solution of a thermosensitive polymer, a purified version of poloxamer 407 having been fractionated in saline. BackStop™, which is injected above the stone, is provided in sterile, pre-filled 2.5ml and 5ml syringes along with and a corresponding injector and a catheter (3F or 5F).
|
No Intervention: Control
n=10 Participants
Patients randomized to the control group will not use any devices to prevent retrograde migration of stones and stone fragments during their ureteroscopic lithotripsy.
|
|---|---|---|
|
Stone-free Rate
Present
|
9 Participants
|
10 Participants
|
|
Stone-free Rate
Absent
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 monthsNeed for secondary procedures of patients who had stone migration
Outcome measures
| Measure |
Investigational: BackStop
n=3 Participants
Patients randomized to the Experimental arm will receive the BackStop gel during their ureteroscopic lithotripsy to prevent retrograde migration of stones or stone fragments.
BackStop: BackStop™ is a FDA approved device. It is intended for use during ureteroscopic lithotripsy to prevent retrograde migration of stones and stone fragments. It is comprised of a solution of a thermosensitive polymer, a purified version of poloxamer 407 having been fractionated in saline. BackStop™, which is injected above the stone, is provided in sterile, pre-filled 2.5ml and 5ml syringes along with and a corresponding injector and a catheter (3F or 5F).
|
No Intervention: Control
n=7 Participants
Patients randomized to the control group will not use any devices to prevent retrograde migration of stones and stone fragments during their ureteroscopic lithotripsy.
|
|---|---|---|
|
Need for Secondary Procedures
Yes
|
0 Participants
|
0 Participants
|
|
Need for Secondary Procedures
No
|
3 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Minutes during SurgeryPopulation: The control group did not receive BackStop injection
Time required to deliver BackStop beginning with insertion of BackStop catheter and ending with its removal subsequent to the delivery of BackStop
Outcome measures
| Measure |
Investigational: BackStop
n=17 Participants
Patients randomized to the Experimental arm will receive the BackStop gel during their ureteroscopic lithotripsy to prevent retrograde migration of stones or stone fragments.
BackStop: BackStop™ is a FDA approved device. It is intended for use during ureteroscopic lithotripsy to prevent retrograde migration of stones and stone fragments. It is comprised of a solution of a thermosensitive polymer, a purified version of poloxamer 407 having been fractionated in saline. BackStop™, which is injected above the stone, is provided in sterile, pre-filled 2.5ml and 5ml syringes along with and a corresponding injector and a catheter (3F or 5F).
|
No Intervention: Control
Patients randomized to the control group will not use any devices to prevent retrograde migration of stones and stone fragments during their ureteroscopic lithotripsy.
|
|---|---|---|
|
Time for BackStop Injection
|
3.04 minutes
Interval 0.43 to 14.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: during surgeryDuration of Lithotripsy Procedure
Outcome measures
| Measure |
Investigational: BackStop
n=17 Participants
Patients randomized to the Experimental arm will receive the BackStop gel during their ureteroscopic lithotripsy to prevent retrograde migration of stones or stone fragments.
BackStop: BackStop™ is a FDA approved device. It is intended for use during ureteroscopic lithotripsy to prevent retrograde migration of stones and stone fragments. It is comprised of a solution of a thermosensitive polymer, a purified version of poloxamer 407 having been fractionated in saline. BackStop™, which is injected above the stone, is provided in sterile, pre-filled 2.5ml and 5ml syringes along with and a corresponding injector and a catheter (3F or 5F).
|
No Intervention: Control
n=18 Participants
Patients randomized to the control group will not use any devices to prevent retrograde migration of stones and stone fragments during their ureteroscopic lithotripsy.
|
|---|---|---|
|
Duration of Lithotripsy Procedure
|
4.17 minutes
Interval 0.08 to 30.0
|
6.09 minutes
Interval 0.1 to 28.0
|
Adverse Events
Investigational: BackStop
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
No Intervention: Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Investigational: BackStop
n=17 participants at risk
Patients randomized to the Experimental arm will receive the BackStop gel during their ureteroscopic lithotripsy to prevent retrograde migration of stones or stone fragments.
BackStop: BackStop™ is a FDA approved device. It is intended for use during ureteroscopic lithotripsy to prevent retrograde migration of stones and stone fragments. It is comprised of a solution of a thermosensitive polymer, a purified version of poloxamer 407 having been fractionated in saline. BackStop™, which is injected above the stone, is provided in sterile, pre-filled 2.5ml and 5ml syringes along with and a corresponding injector and a catheter (3F or 5F).
|
No Intervention: Control
n=18 participants at risk
Patients randomized to the control group will not use any devices to prevent retrograde migration of stones and stone fragments during their ureteroscopic lithotripsy.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
17.6%
3/17 • Number of events 3
|
0.00%
0/18
|
|
Renal and urinary disorders
Urinary Retention
|
5.9%
1/17 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
nausea
|
11.8%
2/17 • Number of events 2
|
0.00%
0/18
|
|
Gastrointestinal disorders
vomiting
|
11.8%
2/17 • Number of events 2
|
0.00%
0/18
|
|
Renal and urinary disorders
hematuria
|
5.9%
1/17 • Number of events 1
|
0.00%
0/18
|
|
General disorders
fever
|
5.9%
1/17 • Number of events 1
|
0.00%
0/18
|
|
Renal and urinary disorders
Urethral Pain
|
5.9%
1/17 • Number of events 1
|
0.00%
0/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place