Kidney StoneNCT07881822
Novel Antimicrobial Solution to Prevent Infections
An observational study of Kidney Stone and Infection, run by Ohio State University.
Trial summary
Ureteroscopy is the most common surgical treatment for kidney stones. Although rare, sepsis after ureteroscopy can be a life-threatening complication, occuring in <3% of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone, Infection, Infection Associated With Catheter
- What is being tested?
- antimicrobial irrigation
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Mar 2027
- How long will I take part?
- 90 Days
- Phase
- Observational
- 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
Study population: anyone who is undergoing ureteroscopy for kidney stone treatment
Who may be able to join
- candidate for ureteroscopic stone removal
Who cannot join
- < 18 years old
- women who are pregnant or breast feeding
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Trial of a Novel Antimicrobial Solution to Reduce Infections After Ureteroscopy
Ureteroscopy is the most common surgical treatment for kidney stones. Although rare, sepsis after ureteroscopy can be a life-threatening complication, occuring in <3% of patients. There are several risk factors for sepsis including history of positive urine culture, pre-existing ureteral stent, or patients with chronic catheters/tubes. the investigators want to study if an antimicrobial solution with chlorhexidine can prevent infections if instilled into the kidney prior to starting ureteroscopy.
- Conditions
- Kidney Stone, Infection, Infection Associated With Catheter, Sepsis
- Being tested
- antimicrobial irrigation
- Keywords
- kidney stone, nephrolithiasis, ureteroscopy, infection, prevention, infectious complications
- Medical subject headings
- Kidney Calculi, Infections, Catheter-Related Infections, Sepsis, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antimicrobial irrigationDrug
antimicrobial irrigation to be used with ureteroscopy
| Study group | Role | What they receive |
|---|---|---|
| Observational | Treatment with antimicrobial solution Receives: Drug: antimicrobial irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency room visits
compare rates of ED visits in the prospective cohort to historic controls
Measured: 90 days
Secondary outcomes (1)
allergic reaction
any reactions to the antimicrobial solution
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Lee, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881822
- Sponsor's protocol ID
- STUDY20260723
- Status last verified
- Apr 2026
- First submitted
- 13 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This is a proof of concept study with limited outcome data. the investigators will not plan to share individual participant data until later potential randomized prospective trials
Publications
CDC: Summary of Recommendations. Infection Control 2024. Available at: https://www.cdc.gov/infection-control/hcp/cauti/summary-of-recommendations.html, accessed July 24, 2024. 2. Anon: Reducing unnecessary urinary catheter use and other strategies to prevent catheter-associated urinary tract infection: an integrative review | BMJ Quality & Safety. Available at: https://qualitysafety.bmj.com/content/23/4/277, accessed May 15, 2025. 3. Anon: Chlorhexidine Irrigation to Reduce Urinary Tract Infections in Patients with Bladder Cancer Undergoing Radical Cystectomy - NCI. 2016. Available at: https://www.cancer.gov/about-cancer/treatment/clinical-trials/search/v?id=NCI-2024-06347, accessed May 15, 2025. 4. Anon: Bladder instillation with Irrisept in Urinary Retention and Neurogenic Bladder - Clinical Trials Registry - ICH GCP. Available at: https://ichgcp.net/clinical-trials-registry/NCT06163469, accessed May 15, 2025.
Atkins L, Sallis A, Chadborn T, Shaw K, Schneider A, Hopkins S, Bunten A, Michie S, Lorencatto F. Reducing catheter-associated urinary tract infections: a systematic review of barriers and facilitators and strategic behavioural analysis of interventions. Implement Sci. 2020 Jul 6;15(1):44. doi: 10.1186/s13012-020-01001-2.
PubMed 32624002Marschall J, Carpenter CR, Fowler S, Trautner BW; CDC Prevention Epicenters Program. Antibiotic prophylaxis for urinary tract infections after removal of urinary catheter: meta-analysis. BMJ. 2013 Jun 11;346:f3147. doi: 10.1136/bmj.f3147.
PubMed 23757735
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial of a Novel Antimicrobial Solution to Reduce Infections After Ureteroscopy
- ClinicalTrials.gov ID
- NCT07881822
- Acronym / sponsor ID
- STUDY20260723
- Conditions
- Kidney Stone, Infection, Infection Associated With Catheter, Sepsis
- Keywords
- kidney stone, nephrolithiasis, ureteroscopy, infection, prevention, infectious complications
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 19 Oct 2026 (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.
Ureteroscopy is the most common surgical treatment for kidney stones. Although rare, sepsis after ureteroscopy can be a life-threatening complication, occuring in <3% of patients. There are several risk factors for sepsis including history of positive urine culture, pre-existing ureteral stent, or patients with chronic catheters/tubes. the investigators want to study if an antimicrobial solution with chlorhexidine can prevent infections if instilled into the kidney prior to starting ureteroscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Drug: antimicrobial irrigationTreatment with antimicrobial solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- anyone who is undergoing ureteroscopy for kidney stone treatment
Key inclusion criteria (1 listed)
- candidate for ureteroscopic stone removal
Key exclusion criteria (2 listed)
- < 18 years old
- women who are pregnant or breast feeding
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 |
|---|---|---|
| antimicrobial irrigationantimicrobial irrigation to be used with ureteroscopy | Drug | Observational |
Primary outcome
Emergency room visits
Time frame: 90 days
compare rates of ED visits in the prospective cohort to historic controls
1 secondary outcome
allergic reaction
Time frame: 30 days
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 23 Oct 2026.
- BackgroundCDC: Summary of Recommendations. Infection Control 2024. Available at: https://www.cdc.gov/infection-control/hcp/cauti/summary-of-recommendations.html, accessed July 24, 2024. 2. Anon: Reducing unnecessary urinary catheter use and other strategies to prevent catheter-associated urinary tract infection: an integrative review | BMJ Quality & Safety. Available at: https://qualitysafety.bmj.com/content/23/4/277, accessed May 15, 2025. 3. Anon: Chlorhexidine Irrigation to Reduce Urinary Tract Infections in Patients with Bladder Cancer Undergoing Radical Cystectomy - NCI. 2016. Available at: https://www.cancer.gov/about-cancer/treatment/clinical-trials/search/v?id=NCI-2024-06347, accessed May 15, 2025. 4. Anon: Bladder instillation with Irrisept in Urinary Retention and Neurogenic Bladder - Clinical Trials Registry - ICH GCP. Available at: https://ichgcp.net/clinical-trials-registry/NCT06163469, accessed May 15, 2025.
- Background: PubMed 32624002Atkins L, Sallis A, Chadborn T, Shaw K, Schneider A, Hopkins S, Bunten A, Michie S, Lorencatto F. Reducing catheter-associated urinary tract infections: a systematic review of barriers and facilitators and strategic behavioural analysis of interventions. Implement Sci. 2020 Jul 6;15(1):44. doi: 10.1186/s13012-020-01001-2.
- Background: PubMed 23757735Marschall J, Carpenter CR, Fowler S, Trautner BW; CDC Prevention Epicenters Program. Antibiotic prophylaxis for urinary tract infections after removal of urinary catheter: meta-analysis. BMJ. 2013 Jun 11;346:f3147. doi: 10.1136/bmj.f3147.
- Individual participant dataSharing planned: No. This is a proof of concept study with limited outcome data. the investigators will not plan to share individual participant data until later potential randomized prospective trials
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stone and Infection, run by Ohio State University.
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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 principal investigator (614-685-9181, matthew.lee@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency room visits (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07881822, which also lists 3 linked publications.
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 23 Oct 2026.