Bladder CancerTURBTNCT05027412
En Bloc TURBT With Collins Loop vs Conventional TURBT
A study testing En bloc TURBT Collins Loop and Conventional TURBT in people with Bladder Cancer and Bladder Neoplasm, run by Hospital Universitario de Fuenlabrada at 1 site in Spain.
Trial summary
This is a prospective, randomized, randomized and single-blind study in patients diagnosed with primary bladder CV. Patients diagnosed by cystoscopy of a bladder tumor and with indication for endoscopic surgical treatment, who meet the inclusion criteria, and who sign the Informed Consent (IC), will be randomized. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Bladder Neoplasm, Bladder Urothelial Carcinoma
- What is being tested?
- En bloc TURBT Collins Loop and Conventional TURBT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2021to Jun 2023
- 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
- >18 years old.
- Polypoid / sessile primary tumor.
- < 3 tumors
- Tumor size 10 - 30 mm.
Who cannot join
- > 4 tumors
- Size of the largest tumor <1 cm and> 4 cm.
- Tumor located in the bladder dome.
- No visualization of the ureteral meatus.
- Flat or in situ tumor.
- Non-urothelial tumors.
- Clotting disorder or treatment with oral anticoagulants.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942
Hugo Otaola Arca, M.D., Ph.D., +56 9 4108 9452, hugotaolarca@hotmail.com
Hugo Otaola Arca, M.D., Ph.D.
About this study
Official title: Transurethral En Bloc Resection With Collins Loop vs Conventional Transurethral Resection for the Treatment of Urothelial Bladder Carcinoma
This is a prospective, randomized, randomized and single-blind study in patients diagnosed with primary bladder CV. Patients diagnosed by cystoscopy of a bladder tumor and with indication for endoscopic surgical treatment, who meet the inclusion criteria, and who sign the Informed Consent (IC), will be randomized.
Read the detailed description
The main objective of the study is to assess the quality of the resection, defined as the presence of detrusor muscle in the resected tissue.
The secondary objetives are:
- Compare the surgical time, hospital stay, urinary catheterization time and incidence of complications.
- Compare tumor recurrence after one year of follow up.
- Determine the number of re-TURB as a consequence of the absence of muscle layer in the sample or artifacts (Tx)
- Establish the incidence of conversions as a consequence of difficulties in the technique or intraoperative bleeding.
- Compare the degree of satisfaction of the surgeon
- Conditions
- Bladder Cancer, Bladder Neoplasm, Bladder Urothelial Carcinoma, Bladder Cancer Stage, Urothelial Carcinoma Recurrent
- Being tested
- En bloc TURBT Collins Loop, Conventional TURBT
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
En bloc TURBT Collins LoopDevice
En bloc TURBT Collins Loop
Conventional TURBTDevice
Conventional TURBT
| Study group | Role | What they receive |
|---|---|---|
| En Bloc TURBT with Collins Loop | Experimental | If the patient is randomized to the TURB group, it will be carried out with a Collins loop, with bipolar energy.
After randomization, demographic data (age, sex, exposure to tobacco, occupational risk), symptoms prior to randomization (micro or macrohematuria, LUTS) and laboratory data (urinary cytology, hemoglobin and serum creatinine) will be collected. Finally, the physical characteristics of the lesion will be noted in the cystoscopy immediately prior to the intervention: size, location (s) and appearance of the tumor. After the intervention, the type of procedure (TURB / TUB), the duration of the procedure from when the resector is inserted until the urinary catheter is placed, and complications according to the Clavien-Dindo scale will be recorded. In your first post-surgical check-up, the days of hospital stay and the time of bladder catheterization will be collected. Receives: Device: En bloc TURBT Collins Loop |
| Conventional TURBT | Active comparator | The TURB will be carried out with bipolar current according to the traditional technique. Receives: Device: Conventional TURBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of detrusor muscle in the resected sample
yes/no
Measured: 1 year of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Apr 2021
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Fuenlabrada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berta Nasarre, Hospital Universitario de Fuenlabrada
- Investigators
- emilio f ripalda, MD, Principal investigator, Hospital Universitario de Fuenlabrada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027412
- Sponsor's protocol ID
- URO
- Acronym
- TURBT
- Status last verified
- Aug 2021
- First submitted
- 24 Aug 2021
- Last updated
- 30 Aug 2021
- 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 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transurethral En Bloc Resection With Collins Loop vs Conventional Transurethral Resection for the Treatment of Urothelial Bladder Carcinoma
- ClinicalTrials.gov ID
- NCT05027412
- Acronym / sponsor ID
- TURBT / URO
- Conditions
- Bladder Cancer, Bladder Neoplasm, Bladder Urothelial Carcinoma, Bladder Cancer Stage, Urothelial Carcinoma Recurrent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital Universitario de FuenlabradaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 30 Aug 2021 (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.
This is a prospective, randomized, randomized and single-blind study in patients diagnosed with primary bladder CV. Patients diagnosed by cystoscopy of a bladder tumor and with indication for endoscopic surgical treatment, who meet the inclusion criteria, and who sign the Informed Consent (IC), will be randomized.
Detailed description
The main objective of the study is to assess the quality of the resection, defined as the presence of detrusor muscle in the resected tissue.
The secondary objetives are:
- Compare the surgical time, hospital stay, urinary catheterization time and incidence of complications.
- Compare tumor recurrence after one year of follow up.
- Determine the number of re-TURB as a consequence of the absence of muscle layer in the sample or artifacts (Tx)
- Establish the incidence of conversions as a consequence of difficulties in the technique or intraoperative bleeding.
- Compare the degree of satisfaction of the surgeon
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| En Bloc TURBT with Collins Loop | Experimental | Device: En bloc TURBT Collins LoopIf the patient is randomized to the TURB group, it will be carried out with a Collins loop, with bipolar energy. After randomization, demographic data (age, sex, exposure to tobacco, occupational risk), symptoms prior to randomization (micro or macrohematuria, LUTS) and laboratory data (urinary cytology, hemoglobin and serum creatinine) will be collected. Finally, the physical characteristics of the lesion will be noted in the cystoscopy immediately prior to the intervention: size, location (s) and appearance of the tumor. After the intervention, the type of procedure (TURB / TUB), the duration of the procedure from when the resector is inserted until the urinary catheter is placed, and complications according to the Clavien-Dindo scale will be recorded. In your first post-surgical check-up, the days of hospital stay and the time of bladder catheterization will be collected. |
| Conventional TURBT | Active comparator | Device: Conventional TURBTThe TURB will be carried out with bipolar current according to the traditional technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18 years old.
- Polypoid / sessile primary tumor.
- < 3 tumors
- Tumor size 10 - 30 mm.
Key exclusion criteria (7 listed)
- > 4 tumors
- Size of the largest tumor <1 cm and> 4 cm.
- Tumor located in the bladder dome.
- No visualization of the ureteral meatus.
- Flat or in situ tumor.
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 |
|---|---|---|
| En bloc TURBT Collins LoopEn bloc TURBT Collins Loop | Device | En Bloc TURBT with Collins Loop |
| Conventional TURBTConventional TURBT | Device | Conventional TURBT |
Primary outcome
presence of detrusor muscle in the resected sample
Time frame: 1 year of follow up
yes/no
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Bladder Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingPhase 1
Study Investigating Intravesical HDAC Inhibition to Improve Response to Immuno-Oncology Agents
Bladder Cancer
RecruitingPhase 3
Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Intermediate Risk Non-Muscle Invasive Bladder Cancer
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.
emilio f ripalda, MD principal investigator
Hospital Universitario de Fuenlabrada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing En bloc TURBT Collins Loop and Conventional TURBT in people with Bladder Cancer and Bladder Neoplasm, run by Hospital Universitario de Fuenlabrada at 1 site in Spain.
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 7 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: status not confirmed, as of the sponsor's last update on 30 Aug 2021. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact emilio A ripalda, MD (+34916006000 ext. 6185, emilio.ripalda@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of detrusor muscle in the resected sample (time frame: 1 year of follow up). 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 30 Aug 2021.