
Clinical Evaluation of a Compliant, Degradable Ureteral Stent to Reduce Patient Pain and Improve TolerabilityAward last edited on: 2/15/2024
Sponsored Program
SBIRAwarding Agency
NIH : NIDDKTotal Award Amount
$1,878,846Award Phase
2Solicitation Topic Code
847Principal Investigator
Jennifer CartledgeCompany Information
Phase I
Contract Number: 1R44DK125243-01Start Date: 7/1/2020 Completed: 6/30/2022
Phase I year
2020Phase I Amount
$999,827Public Health Relevance Statement:
PROJECT NARRATIVE Over the past 50 years, ureteral stenting has gained widespread acceptance to reduce the risk of significant harm from kidney stone management procedures; however, side effects are common with up to 80% of patients experiencing pain and discomfort as a direct result of the stent while implanted and due to the required secondary removal procedure leading to prevalent use of opioids. Incontinence is also a currently accepted result due to stenting. This SBIR proposal aims to validate, through a clinical trial, performance improvements associated with Uriprene®, a degradable ureteral stent, including objective and subjective evaluation of safety, efficacy, pain and a reduction in anticipated incontinence rates. Successful completion of this work will directly translate to a marketed product through support of the 510(k) regulatory pathway and provide scientific evidence to support the benefits of the product for broad adoption.
Project Terms:
Adoption; Adult; 21+ years old; Adult Human; adulthood; Analgesics; Analgesic Agents; Analgesic Drugs; Analgesic Preparation; Anodynes; Antinociceptive Agents; Antinociceptive Drugs; pain killer; pain medication; pain reliever; painkiller; Animals; Bladder; Bladder Urinary System; urinary bladder; Clinical Research; Clinical Study; Clinical Trials; Communication; Disadvantaged; Disease; Disorder; Drainage procedure; Drainage; Feedback; Flank Pain; Health; Human; Modern Man; Hydronephrosis; Incidence; Incontinence; Interview; Kidney; Kidney Urinary System; renal; Kidney Calculi; Kidney Stones; Renal Calculi; Renal Stone; Laboratories; Literature; Pain; Painful; Legal patent; Patents; Patients; Publishing; Quality of life; QOL; Questionnaires; Radiology Specialty; General Radiology; Radiology; Risk; Safety; Stents; Technology; Translating; Urinary Incontinence; Urination; micturition; Urine; Urine Urinary System; Work; Diagnostic radiologic examination; Conventional X-Ray; Diagnostic Radiology; Diagnostic X-Ray; Diagnostic X-Ray Radiology; Radiography; Roentgenography; X-Ray Imaging; X-Ray Medical Imaging; Xray imaging; Xray medical imaging; conventional Xray; diagnostic Xray; diagnostic Xray radiology; Measures; Dietary Habits; eating habit; Diet Habits; Outcome Measure; base; improved; Procedures; Ureteroscopy; Site; Clinical; Medical; Evaluation; Opiates; Opioid; Tubular; Tubular formation; tool; Knowledge; Severities; Event; Source; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; Operative Surgical Procedures; meetings; experience; Performance; Structure; Devices; Reporting; Abscission; Extirpation; Removal; Surgical Removal; resection; Excision; response; Adverse Experience; Adverse event; Intervention Strategies; interventional strategy; Intervention; preventing; prevent; Address; Symptoms; Regulatory Pathway; Clinical Evaluation; Clinical Testing; clinical test; research clinical testing; SBIR; Small Business Innovation Research; Small Business Innovation Research Grant; Validation; Monitor; Active Follow-up; active followup; follow up; followed up; followup; follow-up; imaging; Image; preclinical; pre-clinical; designing; design; clinical site; clinical research site; Outcome; Population; prospective; Implant; implantation; stem; standard of care; pre-clinical evaluation; preclinical evaluation; licit opioid; opiate medication; opioid medication; prescribed opiate; prescribed opioid; prescription opiate; prescription opioid; arm; Sedentary behavior; Sedentary life-style; sedentary lifestyle; predictive outcomes; predictors of outcomes; outcome prediction; improved outcome; opiate consumption; opiate drug use; opiate intake; opiate use; opioid consumption; opioid drug use; opioid intake; opioid use; recruit; pain score; side effect; adverse event monitoring
Phase II
Contract Number: 5R44DK125243-02Start Date: 7/1/2020 Completed: 6/30/2024
Phase II year
2023Phase II Amount
$879,019Public Health Relevance Statement:
PROJECT NARRATIVE Over the past 50 years, ureteral stenting has gained widespread acceptance to reduce the risk of significant harm from kidney stone management procedures; however, side effects are common with up to 80% of patients experiencing pain and discomfort as a direct result of the stent while implanted and due to the required secondary removal procedure leading to prevalent use of opioids. Incontinence is also a currently accepted result due to stenting. This SBIR proposal aims to validate, through a clinical trial, performance improvements associated with Uriprene®, a degradable ureteral stent, including objective and subjective evaluation of safety, efficacy, pain and a reduction in anticipated incontinence rates. Successful completion of this work will directly translate to a marketed product through support of the 510(k) regulatory pathway and provide scientific evidence to support the benefits of the product for broad adoption.
Project Terms:
Adoption; 21+ years old; Adult Human; adulthood; Adult; Analgesic Agents; Analgesic Drugs; Analgesic Preparation; Anodynes; Antinociceptive Agents; Antinociceptive Drugs; pain killer; pain medication; pain reliever; painkiller; Analgesics; Animals; Bladder; Bladder Urinary System; urinary bladder; Clinical Research; Clinical Study; Clinical Trials; Communication; Disadvantaged; Disease; Disorder; Drainage procedure; Drainage; Feedback; Flank Pain; Health; Human; Modern Man; Hydronephrosis; Incidence; Incontinence; Interview; Kidney; Kidney Urinary System; renal; Kidney Calculi; Kidney Stones; Renal Calculi; Renal Stone; Laboratories; Literature; Marketing; Pain; Painful; Legal patent; Patents; Patients; Publishing; Quality of life; QOL; Questionnaires; Radiology Specialty; General Radiology; Radiology; Safety; Stents; Technology; Translating; Urinary Incontinence; Urination; micturition; Urine; Work; Measures; Dietary Habits; eating habit; Diet Habits; measurable outcome; outcome measurement; Outcome Measure; improved; Procedures; Ureteroscopy; Site; Clinical; Medical; Evaluation; Opiates; Opioid; Tubular formation; Tubular; tool; Knowledge; Severities; Event; Source; Operative Surgical Procedures; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; meetings; meeting; experience; Performance; Structure; Devices; Reporting; Excision; Abscission; Extirpation; Removal; Surgical Removal; resection; response; Adverse event; Adverse Experience; Intervention; Intervention Strategies; interventional strategy; reduce risk; reduce risks; reduce that risk; reduce the risk; reduce these risks; reduces risk; reduces the risk; reducing risk; reducing the risk; risk-reducing; Risk Reduction; preventing; prevent; Address; Symptoms; Regulatory Pathway; research clinical testing; Clinical Evaluation; Clinical Testing; clinical test; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Monitor; follow-up; Active Follow-up; active followup; follow up; followed up; followup; Image; imaging; pre-clinical; preclinical; designing; design; clinical site; clinical research site; Outcome; Population; prospective; Implant; implantation; stem; standard of care; pre-clinical evaluation; preclinical evaluation; licit opioid; opiate medication; opioid medication; prescribed opiate; prescribed opioid; prescription opiate; prescription opioid; arm; Sedentary behavior; Sedentary life-style; sedentary lifestyle; predictive outcomes; predictors of outcomes; outcome prediction; improved outcome; opiate consumption; opiate drug use; opiate intake; opiate use; opioid consumption; opioid drug use; opioid intake; opioid use; Radiography; Roentgenography; radiologic imaging; radiological imaging; recruit; pain score; side effect; safety assessment; adverse event monitoring; validate efficacy; efficacy validation; design verification; design validation