Urolithiasis of BladderNCT06373419
TFL vs MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors
A study testing TFL and MOSES holmium laser in people with Urolithiasis of Bladder, run by Thunder Bay Regional Health Research Institute at 1 site in Canada.
Trial summary
The goal of this randomized clinical trial is to determine if there is difference in pathological and clinical outcomes between MOSES and TFL in the transurethral laser enucleation of bladder tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis of Bladder
- What is being tested?
- TFL and MOSES holmium laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 16 Oct 2023to 28 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Over 18 years of age at the time of enrollment.
- Patients presented with visual criteria suggesting bladder tumor by outpatient cystoscopy will be legible for inclusion.
Who cannot join
- Tumors deemed not eligible for laser resection as determined by the Urologist e.g. obvious muscle-invasive or metastatic at presentation
- Synchronous either urethral tumors or upper urinary tract tumor
- History of Carcinoma in situ
- Contracted bladder
Trial locations and contacts
1 site in 1 country.
Canada1 site
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
About this study
Official title: Thulium Fiber Laser (TFL) Versus MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors: A Randomized Controlled Clinical Study
The goal of this randomized clinical trial is to determine if there is difference in pathological and clinical outcomes between MOSES and TFL in the transurethral laser enucleation of bladder tumors.
The main question it aims to answer is:
Is there a difference in pathological and clinical outcomes between MOSES Holmium and Thulium Fiber Laser (TFL) in the transurethral laser enucleation of bladder tumors?
Participants will randomized to either TFL of MOSES arm for their bladder resection procedure.
Read the detailed description
An estimated 12,500 Canadians are diagnosed with bladder cancer each year. Diagnosis and treatment involve transurethral (through the urethra) resection of tumor or tissue called the TURBT procedure. This procedure yields excellent results and minimal morbidity and mortality but has a high recurrence rate, difficulties in the pathologic interpretation of the specimen (due to cautery effect), and procedure-related complications (excessive bleeding, bladder perforation, bowel injury, and inadvertent extensive injury to urethra) that may delay treatments such as chemotherapy which would further impact oncologic outcomes. With the advancement of technology, new methods of transurethral tumor removal have emerged, such as the use of laser energy. Using laser energy, the tumour is resected in one piece, whereas the TURBT approach requires breaking the tumor into pieces. This allows for better pathology analysis that can determine treatment pathways for the patient, as well as reduces the risk of complications. The standard lasers used have been the MOSES Holmium laser and the Thulium Fiber Laser (TFL).
- Conditions
- Urolithiasis of Bladder
- Being tested
- TFL, MOSES holmium laser
- Medical subject headings
- Urinary Bladder Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TFLDevice
Participant undergoing bladder tumour resection that has been randomized to this arm.
MOSES holmium laserDevice
Participant undergoing bladder tumour resection that has been randomized to this arm.
| Study group | Role | What they receive |
|---|---|---|
| Thulium Fibre Laser | Active comparator | Participants randomized to this arm will undergo bladder resection using the TFL laser Receives: Device: TFL |
| MOSES Holmonium | Active comparator | Participants randomized to this arm will undergo bladder resection using the MOSES holmium laser. Receives: Device: MOSES holmium laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of muscularis propria
Presence of muscularis propria (bladder muscle cells) in the pathology sample of the bladder tumour
Measured: 1 day post-procesure
Incidence of inconclusive pathology
Incidence of inconclusive pathology due to specimen artifact
Measured: 1 day post-procedure
Secondary outcomes (10)
Tumor-free rate (TFR)
As per the follow-up cystoscopy, TFR is defined as the absence of any residual tumor detectable by cystoscopy.
Measured: 6 to 12 weeks post-procedure
Total operative time
In minutes measured from anesthesia induction until placement of the urethral catheter
Measured: Intraoperative
Total procedural time
In minutes, measured from the time the cystoscope sheath is inserted into the participant to the time the cystoscope has been removed
Measured: Intraoperative
Number of recurrences
Defined as any tumor detection by follow-up cystoscopy after the initial resection
Measured: 12 weeks post-procedure
Total blood loss
Defined as a drop in hemoglobin level from pre-op
Measured: 6 hours post-procedure
Rate of complications
Percentage of participants with post-operative complications
Measured: 4 weeks post-procedure
Number of inconclusive pathology
Number of inconclusive pathology due to thermal effect artifact.
Measured: 1 day post-procedure
Lasing time
In minutes, defined as the time the laser was in use, not including pedal pauses
Measured: Intraoperative
Total energy used
Measured in kilojoules
Measured: Intraoperative
Frequency and severity of peri-operative complications
Reported according to Clavien-Dindo
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start16 Oct 2023
- Primary completion28 Sep 2026
- Study completion28 Sep 2026
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urolithiasis of BladderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thunder Bay Regional Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Zakaria Ahmed, Thunder Bay Regional Health Research Institute
- Investigators
- Ahmed Z Ahmed, Principal investigator, Thunder Bay Regional Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373419
- Sponsor's protocol ID
- RP-1007
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 1 Oct 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thulium Fiber Laser (TFL) Versus MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06373419
- Acronym / sponsor ID
- RP-1007
- Conditions
- Urolithiasis of Bladder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Thunder Bay Regional Health Research InstituteUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 28 Sep 2026 (actual)
- Study completion
- 28 Sep 2026 (actual)
- First posted
- 18 Apr 2024 (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 goal of this randomized clinical trial is to determine if there is difference in pathological and clinical outcomes between MOSES and TFL in the transurethral laser enucleation of bladder tumors.
The main question it aims to answer is:
Is there a difference in pathological and clinical outcomes between MOSES Holmium and Thulium Fiber Laser (TFL) in the transurethral laser enucleation of bladder tumors?
Participants will randomized to either TFL of MOSES arm for their bladder resection procedure.
Detailed description
An estimated 12,500 Canadians are diagnosed with bladder cancer each year. Diagnosis and treatment involve transurethral (through the urethra) resection of tumor or tissue called the TURBT procedure. This procedure yields excellent results and minimal morbidity and mortality but has a high recurrence rate, difficulties in the pathologic interpretation of the specimen (due to cautery effect), and procedure-related complications (excessive bleeding, bladder perforation, bowel injury, and inadvertent extensive injury to urethra) that may delay treatments such as chemotherapy which would further impact oncologic outcomes. With the advancement of technology, new methods of transurethral tumor removal have emerged, such as the use of laser energy. Using laser energy, the tumour is resected in one piece, whereas the TURBT approach requires breaking the tumor into pieces. This allows for better pathology analysis that can determine treatment pathways for the patient, as well as reduces the risk of complications. The standard lasers used have been the MOSES Holmium laser and the Thulium Fiber Laser (TFL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thulium Fibre Laser | Active comparator | Device: TFLParticipants randomized to this arm will undergo bladder resection using the TFL laser |
| MOSES Holmonium | Active comparator | Device: MOSES holmium laserParticipants randomized to this arm will undergo bladder resection using the MOSES holmium laser. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 18 years of age at the time of enrollment.
- Patients presented with visual criteria suggesting bladder tumor by outpatient cystoscopy will be legible for inclusion.
Key exclusion criteria (4 listed)
- Tumors deemed not eligible for laser resection as determined by the Urologist e.g. obvious muscle-invasive or metastatic at presentation
- Synchronous either urethral tumors or upper urinary tract tumor
- History of Carcinoma in situ
- Contracted bladder
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 |
|---|---|---|
| TFLParticipant undergoing bladder tumour resection that has been randomized to this arm. | Device | Thulium Fibre Laser |
| MOSES holmium laserParticipant undergoing bladder tumour resection that has been randomized to this arm. | Device | MOSES Holmonium |
Primary outcome
Presence of muscularis propria
Time frame: 1 day post-procesure
Presence of muscularis propria (bladder muscle cells) in the pathology sample of the bladder tumour
Incidence of inconclusive pathology
Time frame: 1 day post-procedure
Incidence of inconclusive pathology due to specimen artifact
10 secondary outcomes
Tumor-free rate (TFR)
Time frame: 6 to 12 weeks post-procedure
Total operative time
Time frame: Intraoperative
Total procedural time
Time frame: Intraoperative
Number of recurrences
Time frame: 12 weeks post-procedure
Total blood loss
Time frame: 6 hours post-procedure
Rate of complications
Time frame: 4 weeks post-procedure
Number of inconclusive pathology
Time frame: 1 day post-procedure
Lasing time
Time frame: Intraoperative
Total energy used
Time frame: Intraoperative
Frequency and severity of peri-operative complications
Time frame: Intraoperative
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ahmed Z Ahmed principal investigator
Thunder Bay Regional Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TFL and MOSES holmium laser in people with Urolithiasis of Bladder, run by Thunder Bay Regional Health Research Institute at 1 site in Canada.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 1 Oct 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 Canada. 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?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of muscularis propria (time frame: 1 day post-procesure). The study lists 2 primary outcomes in all. 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 1 Oct 2026.