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Study has halted prematurely as we were not able to meet our target accrual.
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| Name | Class |
|---|---|
| Urology of Virginia | OTHER |
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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.
During ureteroscopic treatment for ureteral stones, lithotripsy, irrigation, and manipulation of the stone often pushes stone away into the kidney itself. This phenomenon is called retropulsion, which is defined as clinically significant retrograde migration of stone or stone fragments. Movement of stones retrograde into the renal pelvis could potentially add and complicate the surgery further. Often scopes need to be changed in order to reach the stone, and chasing these stones will add time to the surgery and require more valuable resources. Furthermore, sometimes a second operation will need to be done when these retropulsed fragments could not be all found and cleaned out.
A number of devices have been developed to prevent such migration including stone baskets and conical devices. These are wire-based devices which have the potential of injuring the ureter. Because of safety concerns and that there is limited data available on the effectiveness of these devices; these are not widely used by urologists. BackStop has recently been developed as another tool to prevent retropulsion. It is a water soluble gel that is injected proximal to the stone. This creates a physical barrier that prevents stone migration during ureteroscopic lithotripsy for ureteral calculus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BackStop | Experimental | Patients randomized to the Experimental arm will receive the BackStop gel during their ureteroscopic lithotripsy to prevent retrograde migration of stones or stone fragments. |
|
| Control | No Intervention | Patients randomized to the control group will not use any devices to prevent retrograde migration of stones and stone fragments during their ureteroscopic lithotripsy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BackStop | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Prevention of Retrograde Stone or Stone Fragment Migration | Prevention of retrograde stone migration (Yes/No) | At the time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Stone-free Rate | Presence or absence of residual stone fragments at 2 month follow up after lithotripsy | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Need for Secondary Procedures | Need for secondary procedures of patients who had stone migration | Up to 3 months |
| Time for BackStop Injection | Time required to deliver BackStop beginning with insertion of BackStop catheter and ending with its removal subsequent to the delivery of BackStop |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Dunn, M.D. | USC Institute of Urology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Institute of Urology | Los Angeles | California | 90089 | United States | ||
| Urology of Virginia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9334635 | Background | Segura JW, Preminger GM, Assimos DG, Dretler SP, Kahn RI, Lingeman JE, Macaluso JN Jr. Ureteral Stones Clinical Guidelines Panel summary report on the management of ureteral calculi. The American Urological Association. J Urol. 1997 Nov;158(5):1915-21. doi: 10.1016/s0022-5347(01)64173-9. | |
| 11590294 | Background |
| Label | URL |
|---|---|
| FDA MAUDE database online (accessed date July 8, 2007) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Prevention of Retrograde Stone or Stone Fragment Migration | Prevention of retrograde stone migration (Yes/No) | Posted | Count of Participants | Participants | At the time of surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Investigational: 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flank Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Total of 3 participants experienced an adverse event that was not unexpected for standard lithotripsy procedure. None were attributed to BackStop. |
Study was not able to meet target accrual and was closed early. More patients are needed to fully evaluate the clinical effectiveness of BackStop.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew Dunn | USC Intitute of Urology | 323-865-3700 | mdunn@med.usc.edu |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| Minutes during Surgery |
| Duration of Lithotripsy Procedure | Duration of Lithotripsy Procedure | during surgery |
| Virginia Beach |
| Virginia |
| 23462 |
| United States |
| International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use.. ICH harmonized tripartite guideline: Guideline for Good Clinical Practice. J Postgrad Med. 2001 Jan-Mar;47(1):45-50. No abstract available. |
| 10646679 | Background | Hendrikx AJ, Strijbos WE, de Knijff DW, Kums JJ, Doesburg WH, Lemmens WA. Treatment for extended-mid and distal ureteral stones: SWL or ureteroscopy? Results of a multicenter study. J Endourol. 1999 Dec;13(10):727-33. doi: 10.1089/end.1999.13.727. |
| 10360494 | Background | Pardalidis NP, Kosmaoglou EV, Kapotis CG. Endoscopy vs. extracorporeal shockwave lithotripsy in the treatment of distal ureteral stones: ten years' experience. J Endourol. 1999 Apr;13(3):161-4. doi: 10.1089/end.1999.13.161. |
| 12796655 | Background | Chow GK, Patterson DE, Blute ML, Segura JW. Ureteroscopy: effect of technology and technique on clinical practice. J Urol. 2003 Jul;170(1):99-102. doi: 10.1097/01.ju.0000070883.44091.24. |
| 9895254 | Background | Knispel HH, Klan R, Heicappell R, Miller K. Pneumatic lithotripsy applied through deflected working channel of miniureteroscope: results in 143 patients. J Endourol. 1998 Dec;12(6):513-5. doi: 10.1089/end.1998.12.513. |
| 7805707 | Background | Robert M, Bennani A, Guiter J, Averous M, Grasset D. Treatment of 150 ureteric calculi with the Lithoclast. Eur Urol. 1994;26(3):212-5. doi: 10.1159/000475382. |
| 20171695 | Background | Rane A, Bradoo A, Rao P, Shivde S, Elhilali M, Anidjar M, Pace K, D'A Honey JR. The use of a novel reverse thermosensitive polymer to prevent ureteral stone retropulsion during intracorporeal lithotripsy: a randomized, controlled trial. J Urol. 2010 Apr;183(4):1417-21. doi: 10.1016/j.juro.2009.12.023. Epub 2010 Feb 20. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| 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. |
|
|
| Secondary | Stone-free Rate | Presence or absence of residual stone fragments at 2 month follow up after lithotripsy | Number of patients analyzed is inconsistent with numbers provided in participant flow module due to patients lost to follow up | Posted | Count of Participants | Participants | 2 months |
|
|
|
| Other Pre-specified | Need for Secondary Procedures | Need for secondary procedures of patients who had stone migration | Posted | Count of Participants | Participants | Up to 3 months |
|
|
|
| Other Pre-specified | Time for BackStop Injection | Time required to deliver BackStop beginning with insertion of BackStop catheter and ending with its removal subsequent to the delivery of BackStop | The control group did not receive BackStop injection | Posted | Mean | Full Range | minutes | Minutes during Surgery |
|
|
|
| Other Pre-specified | Duration of Lithotripsy Procedure | Duration of Lithotripsy Procedure | Posted | Mean | Full Range | minutes | during surgery |
|
|
|
| 0 |
| 17 |
| 4 |
| 17 |
| EG001 | 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. | 0 | 18 | 0 | 18 |
|
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| hematuria | Renal and urinary disorders | Systematic Assessment |
|
| fever | General disorders | Systematic Assessment |
|
| Urethral Pain | Renal and urinary disorders | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |