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Laser Therapy

Thulium Fibre Laser for Bladder stones

N/A

Recruiting

Led By Ahmed Z Ahmed

Research Sponsored by Thunder Bay Regional Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Over 18 years of age at the time of enrollment

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 to 12 weeks post-procedure

Awards & highlights

Study Summary

This trial aims to compare the outcomes of using two different types of lasers (MOSES and TFL) in the removal of bladder tumors. Participants will be randomly assigned to receive either MOSES or T

Who is the study for?

This trial is for adults over 18 who have visible bladder tumors identified by outpatient cystoscopy. It's not for those with urethral or upper urinary tract tumors, a history of carcinoma in situ, contracted bladder, or tumors unsuitable for laser resection like muscle-invasive or metastatic cancers.Check my eligibility

What is being tested?

The study compares two types of lasers: MOSES holmium and Thulium Fiber Laser (TFL), used in the transurethral enucleation of bladder tumors. Participants will be randomly assigned to either the TFL or MOSES group for their procedure.See study design

What are the potential side effects?

While specific side effects are not listed here, laser procedures may include risks such as bleeding, infection, pain during urination, urinary frequency/urgency changes and potential injury to surrounding tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intraoperative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~intraoperative

This trial's timeline: 3 weeks for screening, Varies for treatment, and intraoperative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of inconclusive pathology

Presence of muscularis propria

Secondary outcome measures

Frequency and severity of peri-operative complications

Lasing time

Number of inconclusive pathology

+7 more

Trial Design

2Treatment groups

Active Control

Group I: Thulium Fibre LaserActive Control1 Intervention

Participants randomized to this arm will undergo bladder resection using the TFL laser

Group II: MOSES HolmoniumActive Control1 Intervention

Participants randomized to this arm will undergo bladder resection using the MOSES holmium laser.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Thunder Bay Regional Health Research InstituteLead Sponsor

9 Previous Clinical Trials

834 Total Patients Enrolled

Ahmed Z AhmedPrincipal InvestigatorThunder Bay Regional Health Sciences Centre

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants currently being accepted for enrollment in this clinical trial?

"As per clinicaltrials.gov, this trial is actively enrolling participants. It was initially registered on October 16th, 2023 and last modified on April 17th, 2024."

Answered by AI

What is the current number of individuals involved in this clinical trial as participants?

"Indeed, the details on clinicaltrials.gov show that this research study is actively seeking participants. The trial was initially listed on October 16, 2023, with the most recent update made on April 17, 2024. They are currently aiming to enroll a total of 100 patients at one specific location."

Answered by AI

What are the main goals that this clinical trial aims to achieve?

"The main focus of this study, assessed within a 24-hour time frame post-procedure, is the occurrence rate of ambiguous pathological results. Additional measures include the entire duration from anesthesia initiation to urethral catheter insertion (Total operative time), the length of time taken from cystoscope sheath introduction to removal (Total procedural time), and instances of tumor reappearance as identified during subsequent cystoscopies following initial resection."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TFL vs MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors

Ahmed Zakaria Ahmed 2023. "TFL vs MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06373419.