MacrohematuriaAIROSCOPYNCT07618221
Air vs. Liquid: A Study on Cystoscopy Performance and Visibility Enhancement in Macrohematuria Cases
A study testing Air-based flexible cystoscopy and Saline-based flexible cystoscopy in people with Macrohematuria, run by Kantonsspital Baden at 1 site in Switzerland.
Trial summary
Macroscopic haematuria is a common urological emergency. Diagnostic cystoscopy is the gold standard for identifying the bleeding source; however, blood and clots within the bladder significantly impair endoscopic visibility when saline is used as the distension medium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macrohematuria
- What is being tested?
- Air-based flexible cystoscopy and Saline-based flexible cystoscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2026to 1 Jun 2028
- 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
- Persistent macroscopic haematuria Grade III-V within 48 hours after hospitalisation
- Age ≥ 18 years
- Unexplained macroscopic haematuria requiring diagnostic cystoscopy
- Ability to give written informed consent
Who cannot join
- Pregnant or lactating women
- Haemodynamic instability or urgent need for operative or interventional cystoscopy (requiring cystoscopy within < 24 hours of screening)
- Ureteral stent in situ
- Active urinary tract infection
- Transurethral resection of the bladder (TURB) or prostate (TURP) within the last 6 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Kantonsspital Baden AG, Department of Urology
Baden, Canton of Aargau, 5404
Lasse Petersen, Dr.med. univ., 0041 56 486 3083, lasse.petersen@ksb.ch
About this study
Official title: AIROSCOPY - A Prospective, Randomized, Controlled, Single-Centre Superiority Study Comparing Air-Based Versus Saline-Based Flexible Cystoscopy for the Identification of the Bleeding Source in Patients With Macroscopic Haematuria
Macroscopic haematuria is a common urological emergency. Diagnostic cystoscopy is the gold standard for identifying the bleeding source; however, blood and clots within the bladder significantly impair endoscopic visibility when saline is used as the distension medium.
Air-based cystoscopy, a technique first described in the 19th century, exploits the immiscibility of gas and blood to maintain clear visualisation even during active bleeding. Despite its theoretical advantages, no randomised clinical data exist to support its use.
Read more
AIROSCOPY is a prospective, randomised, controlled, single-centre superiority study comparing air-based versus saline-based flexible cystoscopy in patients with macroscopic haematuria (Grade III-V). Patients are randomised 1:1. Only the index cystoscopy (first randomised modality) contributes to all study endpoints. A second cystoscopy with the alternative modality is performed solely for patient safety to ensure no diagnostic disadvantage from study participation. This second examination is not analysed.
The primary endpoint is identification of the bleeding source during the index cystoscopy (binary: yes/no). Secondary endpoints include time to source identification, total procedure duration, urologist-rated visibility (Likert scale), and patient comfort (Likert scale).
Read the detailed description
Background: Continuous bladder irrigation (CBI) is the current standard management for haematuria, but can delay diagnostic cystoscopy. Gas-based cystoscopy may allow earlier and clearer visualisation of the bladder mucosa.
Design: Prospective, randomised (1:1), controlled, parallel-group, open-label, single-centre superiority trial. Randomisation is stratified by haematuria grade and history of transurethral resection (TUR-B/P), using REDCap.
Intervention: Index cystoscopy with either air (up to 240 ml by syringe) or saline (up to 240 ml by syringe), according to randomisation. A second cystoscopy with the alternative medium follows immediately, exclusively to ensure no diagnostic disadvantage for the patient (results not analysed).
Sample size: N=40 (20 per arm), based on detection rates of 86% (air) vs. 38% (saline), two-sided α=0.05, 80% power, with 20% attrition allowance.
Statistics: Chi-square test (Fisher's exact test) for the primary endpoint; risk ratio and risk difference with 95% CI reported.
- Conditions
- Macrohematuria
- Being tested
- Air-based flexible cystoscopy, Saline-based flexible cystoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air-based flexible cystoscopyProcedure or surgery
Flexible cystoscopy with manual air insufflation (up to 240 ml) via bladder syringe for bladder distension and visualisation.
Saline-based flexible cystoscopyProcedure or surgery
Flexible cystoscopy with manual saline irrigation (up to 240 ml, 0.9% NaCl) via bladder syringe for bladder distension and visualisation.
| Study group | Role | What they receive |
|---|---|---|
| Air Cystoscopy | Experimental | Flexible cystoscopy using air as the distension medium (up to 240 ml, manually administered via bladder syringe). This is the index cystoscopy for patients randomised to air. Receives: Procedure: Air-based flexible cystoscopy |
| Saline Cystoscopy | Active comparator | Flexible cystoscopy using 0.9% saline as the distension medium (up to 240 ml, manually administered via bladder syringe). Standard-of-care procedure. This is the index cystoscopy for patients randomised to saline. Receives: Procedure: Saline-based flexible cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the underlying cause of macroscopic haematuria during the index cystoscopy
Binary outcome (yes/no). Assessed in real time by the operating urologist during the index procedure and documented immediately after completion. 'Yes' if a specific bleeding source (e.g., tumour, prostate bleeding, stone, vascular lesion) is identified; 'No' otherwise.
Measured: Immediately after completion of the index cystoscopy (intraoperative)
Secondary outcomes (4)
Time to source identification
Minutes from insertion of the cystoscope to first identification of the bleeding source during the index cystoscopy.
Measured: Intraoperative
Total procedure duration
Minutes from insertion to removal of the cystoscope during the index cystoscopy.
Measured: Intraoperative
Urologist-rated visibility
5-point Likert scale (1 = very poor to 5 = excellent), completed by the operating urologist immediately after the index cystoscopy.
Measured: Immediately after index cystoscopy
Patient comfort
Description: 5-point Likert scale (1 = very uncomfortable to 5 = very comfortable), completed by the patient immediately after the index cystoscopy.
Measured: Immediately after index cystoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MacrohematuriaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Flexible cystoscopy using air as the distension medium (up to 240 ml, manually administered via bladder syringe). This is the index cystoscopy for patients randomised to air.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Baden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukas J Hefermehl, Kantonsspital Baden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618221
- Sponsor's protocol ID
- 2026-00787
- Other IDs
- 2026-00787
- Acronym
- AIROSCOPY
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIROSCOPY - A Prospective, Randomized, Controlled, Single-Centre Superiority Study Comparing Air-Based Versus Saline-Based Flexible Cystoscopy for the Identification of the Bleeding Source in Patients With Macroscopic Haematuria
- ClinicalTrials.gov ID
- NCT07618221
- Acronym / sponsor ID
- AIROSCOPY / 2026-00787
- Conditions
- Macrohematuria
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kantonsspital BadenUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 1 Jun 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.
Macroscopic haematuria is a common urological emergency. Diagnostic cystoscopy is the gold standard for identifying the bleeding source; however, blood and clots within the bladder significantly impair endoscopic visibility when saline is used as the distension medium.
Air-based cystoscopy, a technique first described in the 19th century, exploits the immiscibility of gas and blood to maintain clear visualisation even during active bleeding. Despite its theoretical advantages, no randomised clinical data exist to support its use.
AIROSCOPY is a prospective, randomised, controlled, single-centre superiority study comparing air-based versus saline-based flexible cystoscopy in patients with macroscopic haematuria (Grade III-V). Patients are randomised 1:1. Only the index cystoscopy (first randomised modality) contributes to all study endpoints. A second cystoscopy with the alternative modality is performed solely for patient safety to ensure no diagnostic disadvantage from study participation. This second examination is not analysed.
The primary endpoint is identification of the bleeding source during the index cystoscopy (binary: yes/no). Secondary endpoints include time to source identification, total procedure duration, urologist-rated visibility (Likert scale), and patient comfort (Likert scale).
Detailed description
Background: Continuous bladder irrigation (CBI) is the current standard management for haematuria, but can delay diagnostic cystoscopy. Gas-based cystoscopy may allow earlier and clearer visualisation of the bladder mucosa.
Design: Prospective, randomised (1:1), controlled, parallel-group, open-label, single-centre superiority trial. Randomisation is stratified by haematuria grade and history of transurethral resection (TUR-B/P), using REDCap.
Intervention: Index cystoscopy with either air (up to 240 ml by syringe) or saline (up to 240 ml by syringe), according to randomisation. A second cystoscopy with the alternative medium follows immediately, exclusively to ensure no diagnostic disadvantage for the patient (results not analysed).
Sample size: N=40 (20 per arm), based on detection rates of 86% (air) vs. 38% (saline), two-sided α=0.05, 80% power, with 20% attrition allowance.
Statistics: Chi-square test (Fisher's exact test) for the primary endpoint; risk ratio and risk difference with 95% CI reported.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Flexible cystoscopy using air as the distension medium (up to 240 ml, manually administered via bladder syringe). This is the index cystoscopy for patients randomised to air.
| Arm | Type | Receives |
|---|---|---|
| Air Cystoscopy | Experimental | Procedure: Air-based flexible cystoscopyFlexible cystoscopy using air as the distension medium (up to 240 ml, manually administered via bladder syringe). This is the index cystoscopy for patients randomised to air. |
| Saline Cystoscopy | Active comparator | Procedure: Saline-based flexible cystoscopyFlexible cystoscopy using 0.9% saline as the distension medium (up to 240 ml, manually administered via bladder syringe). Standard-of-care procedure. This is the index cystoscopy for patients randomised to saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Persistent macroscopic haematuria Grade III-V within 48 hours after hospitalisation
- Age ≥ 18 years
- Unexplained macroscopic haematuria requiring diagnostic cystoscopy
- Ability to give written informed consent
Key exclusion criteria (5 listed)
- Pregnant or lactating women
- Haemodynamic instability or urgent need for operative or interventional cystoscopy (requiring cystoscopy within < 24 hours of screening)
- Ureteral stent in situ
- Active urinary tract infection
- Transurethral resection of the bladder (TURB) or prostate (TURP) within the last 6 weeks
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 |
|---|---|---|
| Air-based flexible cystoscopyFlexible cystoscopy with manual air insufflation (up to 240 ml) via bladder syringe for bladder distension and visualisation. | Procedure or surgery | Air Cystoscopy |
| Saline-based flexible cystoscopyFlexible cystoscopy with manual saline irrigation (up to 240 ml, 0.9% NaCl) via bladder syringe for bladder distension and visualisation. | Procedure or surgery | Saline Cystoscopy |
Primary outcome
Identification of the underlying cause of macroscopic haematuria during the index cystoscopy
Time frame: Immediately after completion of the index cystoscopy (intraoperative)
Binary outcome (yes/no). Assessed in real time by the operating urologist during the index procedure and documented immediately after completion. 'Yes' if a specific bleeding source (e.g., tumour, prostate bleeding, stone, vascular lesion) is identified; 'No' otherwise.
4 secondary outcomes
Time to source identification
Time frame: Intraoperative
Total procedure duration
Time frame: Intraoperative
Urologist-rated visibility
Time frame: Immediately after index cystoscopy
Patient comfort
Time frame: Immediately after index cystoscopy
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 3 Jun 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air-based flexible cystoscopy and Saline-based flexible cystoscopy in people with Macrohematuria, run by Kantonsspital Baden at 1 site in Switzerland.
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 4 inclusion and 5 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 3 Jun 2026. 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 Switzerland. 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 Lasse Petersen, Dr. med. univ. (+41 56 486 3083, lasse.petersen@ksb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of the underlying cause of macroscopic haematuria during the index cystoscopy (time frame: Immediately after completion of the index cystoscopy (intraoperative)). 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 3 Jun 2026.