Renal CalculiNCT00893282
Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy
A study testing BackStop and Intracorporeal lithotripsy without the use of an anti-retropulsion device in people with Renal Calculi and Kidney Stones, run by Pluromed, Inc. at 1 site in Canada.
Trial summary
The purpose of this clinical study is to evaluate BackStop, a polymer-based device that is intended to be used during ureteroscopic lithotripsy to prevent retrograde stone migration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Calculi, Kidney Stones
- What is being tested?
- BackStop and Intracorporeal lithotripsy without the use of an anti-retropulsion device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2008to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a solitary, radio-opaque ureteral stone in the proximal ureter.
- Clinical indication for treatment by ureteroscopic lithotripsy.
- Minimum 18 years old (or any institutional age limits for participation in clinical study).
- Patients must be willing and able to participate in any follow-up visits, as required.
- Patients must provide informed consent.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled, Prospective, Single Blind Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy.
The purpose of this clinical study is to evaluate BackStop, a polymer-based device that is intended to be used during ureteroscopic lithotripsy to prevent retrograde stone migration. It is a water soluble polymer with reverse thermosensitive properties; the polymer exists as a liquid at low temperature (below 17 C) and rapidly transitions to a high viscosity gel at body temperature (i.e. in the ureter). BackStop is injected above the stones in the ureter and is intended to prevent retrograde migration of stones during ureteroscopic lithotripsy. Upon completion of the lithotripsy procedure, BackStop dissolves naturally or by irrigation.
The study hypothesis is that a greater proportion of patients will experience no retropulsion of a kidney stone when BackStop is used versus no anti-retropulsion device when undergoing intracorporeal lithotripsy.
- Conditions
- Renal Calculi, Kidney Stones
- Being tested
- BackStop, Intracorporeal lithotripsy without the use of an anti-retropulsion device
- Keywords
- renal, calculi, kidney, stones
- Medical subject headings
- Kidney Calculi, Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BackStopDevice
BackStop in a gel plug that potentially prevents retropulsion during intracorporeal lithotripsy.
Intracorporeal lithotripsy without the use of an anti-retropulsion deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| BackStop | Experimental | Intracorporeal lithotripsy with the use of an anti-retropulsion device. Receives: Device: BackStop |
| Control | Active comparator | No anti-retropulsion device will be used during lithotripsy. Receives: Device: Intracorporeal lithotripsy without the use of an anti-retropulsion device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of BackStop™ to minimize migration stone fragments in the proximal ureter will and reported as "yes" or "no".
Measured: intra-operative
Secondary outcomes (2)
Extent of residual fragments remaining in ureter at the follow-up visit 2 to 4 weeks post-procedure.
Measured: one month
In the event that stone fragments migrate retrograde, there may be a need for the physician to employ additional procedures
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startFeb 2008
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pluromed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893282
- Sponsor's protocol ID
- BSTP-001
- Status last verified
- May 2009
- First submitted
- 1 May 2009
- Last updated
- 5 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Prospective, Single Blind Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy.
- ClinicalTrials.gov ID
- NCT00893282
- Acronym / sponsor ID
- BSTP-001
- Conditions
- Renal Calculi, Kidney Stones
- Keywords
- renal, calculi, kidney, stones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Pluromed, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study is to evaluate BackStop, a polymer-based device that is intended to be used during ureteroscopic lithotripsy to prevent retrograde stone migration. It is a water soluble polymer with reverse thermosensitive properties; the polymer exists as a liquid at low temperature (below 17 C) and rapidly transitions to a high viscosity gel at body temperature (i.e. in the ureter). BackStop is injected above the stones in the ureter and is intended to prevent retrograde migration of stones during ureteroscopic lithotripsy. Upon completion of the lithotripsy procedure, BackStop dissolves naturally or by irrigation.
The study hypothesis is that a greater proportion of patients will experience no retropulsion of a kidney stone when BackStop is used versus no anti-retropulsion device when undergoing intracorporeal lithotripsy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BackStop | Experimental | Device: BackStopIntracorporeal lithotripsy with the use of an anti-retropulsion device. |
| Control | Active comparator | Device: Intracorporeal lithotripsy without the use of an anti-retropulsion deviceNo anti-retropulsion device will be used during lithotripsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with a solitary, radio-opaque ureteral stone in the proximal ureter.
- Clinical indication for treatment by ureteroscopic lithotripsy.
- Minimum 18 years old (or any institutional age limits for participation in clinical study).
- Patients must be willing and able to participate in any follow-up visits, as required.
- Patients must provide informed consent.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BackStopBackStop in a gel plug that potentially prevents retropulsion during intracorporeal lithotripsy. | Device | BackStop |
| Intracorporeal lithotripsy without the use of an anti-retropulsion device | Device | Control |
Primary outcome
Ability of BackStop™ to minimize migration stone fragments in the proximal ureter will and reported as "yes" or "no".
Time frame: intra-operative
2 secondary outcomes
Extent of residual fragments remaining in ureter at the follow-up visit 2 to 4 weeks post-procedure.
Time frame: one month
In the event that stone fragments migrate retrograde, there may be a need for the physician to employ additional procedures
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2009.
Related trials for Renal Calculi
Not yet recruiting
Automated Versus Manual Irrigation During Flexible Ureteroscopy
Renal Stone Disease
Not yet recruiting
Optimal Intrarenal Pressure During Flexible Ureteroscopy
Renal Stone Disease
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BackStop and Intracorporeal lithotripsy without the use of an anti-retropulsion device in people with Renal Calculi and Kidney Stones, run by Pluromed, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of BackStop™ to minimize migration stone fragments in the proximal ureter will and reported as "yes" or "no". (time frame: intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2009.