Ureteral StrictureENDURE1NCT07020520
EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures
A study testing Optilume in people with Ureteral Stricture, run by Urotronic Inc. at 7 sites in United States.
Trial summary
The main objective of this clinical investigation is to assess the safety and feasibility of the Optilume DCB for treatment of ureteric strictures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Stricture
- What is being tested?
- Optilume
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Oct 2025to 30 Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 years or older
- Single lesion ureteric or uretero-enteric stricture less than or equal to 4.0 cm in length
- Two functioning kidneys
Who cannot join
- Treatment of the target ureter with incision or balloon dilation within 3 months of the study treatment
- Subjects with more than one ureteric stricture
- Subjects with target stricture in bifid or duplicated ureter
- Known sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
- Ureteric stricture caused by extrinsic compression of the ureter
- Unable to endoscopically access target stricture for any reason
Show all 28Show fewer
- Existing stones in the ipsilateral kidney or ureter (except for asymptomatic kidney stones) that are in close proximity to the target ureteric stricture
- Chronic renal failure treated with dialysis
- eGFR <30 mL/min/1.73m2
- Kidney function ≤ 25% of split function on the side with target stricture as measured by functional renogram
- Kidney function ≤35% of split function on the side opposite target stricture as measured by functional renogram or other significant pathology or impairment that may impact renal function
- Life expectancy less than 12 months
- Women who are pregnant or breastfeeding
- Women of child-bearing potential planning to get pregnant in the next year or are unwilling to use contraception over the next 12 months
- Males unwilling to abstain or use protected sex for 30 days post treatment
- Males unwilling to use highly effective contraception for6 months post treatment if sexual partner(s) are of child-bearing potential
- Inability to provide legally effective informed consent
- Unwilling or unable to meet protocol follow-up requirements
- Participation in any interventional clinical investigation of a medical device, drug, or biologic (excluding registries) that may confound the results of the trial
- Active systemic or urinary tract infection
- Active malignancy in the abdomen or pelvis, or any malignancy considered considerable risk for metastasizing to the abdomen or pelvis over the next 12 months
- Uncontrolled diabetes defined as hemoglobin A1C ≥ 8% at baseline
- Unable to come off antiplatelet or anticoagulation medication prior to treatment to prevent bleeding complications at the discretion of the investigator
- Any other condition that may confound the results of the trial or presents an unacceptable risk for any study-related procedure
- Individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response
- Presence of any condition that precludes administration of furosemide during renograms
- Unable to tolerate contrast related to required study procedures or imaging.
- Additional Criteria for Pharmacokinetic Substudy Inclusion Ureteric stricture measurements appropriate for treatment with a 6mm (18F) or 8mm (24F) diameter Optilume DCB Exclusion Prior treatment with any device or medical therapy that contains paclitaxel, including drug coated balloons for vascular and urethral applications
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Reem Ennenga contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75390
Maia VanDyke, MD, 214-645-8765, maiavandyke@utsouthwestern.edu
Maia VanDyke, MD
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Matthew Mellon, MD, 317-962-8401, mjmellon@iu.edu
- Recruiting
Mount Sinai
New York, New York, 10003
Michael Palese, MD, 212-844-8900, michael.palese@mountsinai.org
Michael Palese, MD
- Recruiting
NYU Langone
New York, New York, 10016
Lee Zhao, MD, 646-825-6300, lee.zhao@nyulangone.org
- Recruiting
University of California Irvine
Orange, California, 92868
Jaime Landman, MD, 9498249320, landmanj@hs.uci.edu
Jaime Landman, MD
- Recruiting
Orlando Health
Orlando, Florida, 32806
Lucas Wiegand, MD, 877-876-3627, lucas.wiegand@orlandohealth.com
Lucas Wiegand, MD
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Benjamin McCormick, MD, 801-213-2718, benjamin.mccormick@hsc.utah.edu
Benjamin McCormick, MD
About this study
The main objective of this clinical investigation is to assess the safety and feasibility of the Optilume DCB for treatment of ureteric strictures.
- Conditions
- Ureteral Stricture
- Being tested
- Optilume
- Keywords
- ureteral, ureteric, stricture, stenosis, optilume
- Medical subject headings
- Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptilumeDevice
Has pre-treatment (balloon dilation or ureterotomy) followed by paclitaxel-coated balloon (Optilume) treatment of the ureteric stricture.
| Study group | Role | What they receive |
|---|---|---|
| Optilume | Experimental | Treatment with Optilume for ureteric stricture Receives: Device: Optilume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful treatment
Rate of successful treatment defined as meeting all the following criteria:
- Technical success
- Freedom from retreatment of target stricture through six months post stent removal
- Renogram at 6 months showing stability or improvement in split function for impacted kidney defined as split function within 10% of baseline value or improved from baseline.
- T1/2 stability or improvement from baseline to 6 months for impacted kidney
Measured: 6-months post ureteral stent removal (approximately 7 months post Optilume treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Oct 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral StrictureStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- There is a main study and pharmacokinetic (PK) substudy. All subjects will receive the same treatment. PK substudy subjects (15) will also have serum and urine samples collected for analysis of paclitaxel levels.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Urotronic Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laborie Medical Technologies Inc.
- Responsible party
- Sponsor
- Investigators
- Jamie Landman, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020520
- Sponsor's protocol ID
- 1391
- Acronym
- ENDURE1
- Status last verified
- Mar 2026
- First submitted
- 27 May 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures
- ClinicalTrials.gov ID
- NCT07020520
- Acronym / sponsor ID
- ENDURE1 / 1391
- Conditions
- Ureteral Stricture
- Keywords
- ureteral, ureteric, stricture, stenosis, optilume
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Urotronic Inc.Industry (pharma, biotech, devices)
- Collaborators
- Laborie Medical Technologies Inc.
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Jul 2031 (estimated)
- First posted
- 13 Jun 2025 (actual)
- 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 main objective of this clinical investigation is to assess the safety and feasibility of the Optilume DCB for treatment of ureteric strictures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There is a main study and pharmacokinetic (PK) substudy. All subjects will receive the same treatment. PK substudy subjects (15) will also have serum and urine samples collected for analysis of paclitaxel levels.
| Arm | Type | Receives |
|---|---|---|
| Optilume | Experimental | Device: OptilumeTreatment with Optilume for ureteric stricture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Single lesion ureteric or uretero-enteric stricture less than or equal to 4.0 cm in length
- Two functioning kidneys
Key exclusion criteria (28 listed)
- Treatment of the target ureter with incision or balloon dilation within 3 months of the study treatment
- Subjects with more than one ureteric stricture
- Subjects with target stricture in bifid or duplicated ureter
- Known sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
- Ureteric stricture caused by extrinsic compression of the ureter
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 |
|---|---|---|
| OptilumeHas pre-treatment (balloon dilation or ureterotomy) followed by paclitaxel-coated balloon (Optilume) treatment of the ureteric stricture. | Device | Optilume |
Primary outcome
Successful treatment
Time frame: 6-months post ureteral stent removal (approximately 7 months post Optilume treatment)
Rate of successful treatment defined as meeting all the following criteria: * Technical success * Freedom from retreatment of target stricture through six months post stent removal * Renogram at 6 months showing stability or improvement in split function for impacted kidney defined as split function within 10% of baseline value or improved from baseline. * T1/2 stability or improvement from baseline to 6 months for impacted kidney
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Ureteral Stricture
RecruitingObservational study
Long-term Safety of UAS-assisted vs Sheathless RIRS in Non-prestented Patients
Renal Stone Disease, Ureteral Stricture
Not yet recruitingPhase 4
Dexmedetomidine-Esketamine Combination on Depression and Anxiety After Laparoscopic Ureteral Reconstruction
Ureteral Stricture, Dexmedetomidine
Not yet recruitingObservational study
An Integrated Multi-omics Study on the Molecular Mechanisms of Ureteral Stricture
Ureteral Stricture, Ureteral Obstruction
Recruiting
Tandem Polyurethane Stents Compared to Single Silicone Stent for Malignant Ureteral Obstruction
Hydronephrosis; Obstruction, Ureter, Renal Failure
RecruitingObservational study
Application of the Sentire C1000 for Ureteral Stricture Repair
Ureteral Stricture, Hydronephrosis
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.
Reem Ennenga contact
Jamie Landman, MD principal investigator
University of California, Irvine
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optilume in people with Ureteral Stricture, run by Urotronic Inc. at 7 sites in United States.
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 3 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven M Principal Clinical Project Manager (952-426-6079, smadej@laborie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful treatment (time frame: 6-months post ureteral stent removal (approximately 7 months post Optilume treatment)). 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 9 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.