TCCPhase 1NCT04147182
Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder Tumor Resection
A Phase 1 study testing Hypertonic Saline 3% in people with TCC, run by Dan Leibovici at 1 site in Israel.
Trial summary
Hypertonic saline at the concentration of 3% (hypersel) has been injected for years into echinococcal cysts to kill live scolices, and is also known to kill suspended cells by means of a steep osmotic gradient and the investigators postulate that perioperative intravesical instillation of hypersel for patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TCC
- What is being tested?
- Hypertonic Saline 3%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Dec 2018to 3 Nov 2020
- Phase
- Phase 1
- 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
- Patients of 18 years or older able to sign informed consent
- A previous diagnosis of low grade bladder cancer
- A pyelographic imaging examination (CTU, MRU, IVP, antegrade/retrograde pyelography) showing normal upper urinary tract in the 12 months prior to inclusion
- Serum creatinine levels ≤ 2.0 mg/dl
- Serum sodium levels <146 mg/ml
- Current bladder tumor diagnosed by endoscopy or imaging in the last 3 months
- Patient is candidate for TURBT
Who cannot join
- Previous history of high grade bladder cancer including carcinoma in situ
- Presence of upper urinary tract tumor on imaging
- Renal failure with serum creatinine >2.0 mg/dl prior to inclusion
- Hypernatremia >146 mg/dl prior to inclusion
- Contra-indication to undergo TURBT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder
Hypertonic saline at the concentration of 3% (hypersel) has been injected for years into echinococcal cysts to kill live scolices, and is also known to kill suspended cells by means of a steep osmotic gradient and the investigators postulate that perioperative intravesical instillation of hypersel for patients with low grade bladder cancer is safe and may be active against shedded and suspended tumor cells and thus may decrease recurrence risk.
- Conditions
- TCC
- Being tested
- Hypertonic Saline 3%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic Saline 3%Drug
3% and 5% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. The pH may have been adjusted with hydrochloric acid. It contains no antimicrobial agents.
| Study group | Role | What they receive |
|---|---|---|
| Patient with low grade TCC | Experimental | 1. Patients of 18 years or older able to sign informed consent
2. A previous diagnosis of low grade bladder cancer
3. A pyelographic imaging examination (CTU, MRU, IVP, antegrade/retrograde pyelography) showing normal upper urinary tract in the 12 months prior to inclusion
4. Serum creatinine levels ≤ 2.0 mg/dl
5. Serum sodium levels <146 mg/ml
6. Current bladder tumor diagnosed by endoscopy or imaging in the last 3 months
7. Patient is candidate for TURBT Receives: Drug: Hypertonic Saline 3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events as assessed by Common Terminology Criteriafor Adverse Events of Renal and urinary disorders (CTCAE)Version 5.0,2017, Satisfaction assessed by Clavien-Dindo.
The investigators monitored the Sodium levels in the blood after the administration of the Hypertonic Saline and documented and measure side effects by Clavien-Dindo scale
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start2 Dec 2018
- Primary completion3 Jul 2019
- Study completion3 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TCCStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dan Leibovici
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dan Leibovici, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147182
- Sponsor's protocol ID
- 0116-17-KMC
- Status last verified
- Oct 2019
- First submitted
- 23 Oct 2019
- Last updated
- 4 Nov 2019
- 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 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder
- ClinicalTrials.gov ID
- NCT04147182
- Acronym / sponsor ID
- 0116-17-KMC
- Conditions
- TCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Dan LeiboviciUniversity, hospital or other
- Study start
- 2 Dec 2018 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 3 Nov 2020 (estimated)
- First posted
- 31 Oct 2019 (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.
Hypertonic saline at the concentration of 3% (hypersel) has been injected for years into echinococcal cysts to kill live scolices, and is also known to kill suspended cells by means of a steep osmotic gradient and the investigators postulate that perioperative intravesical instillation of hypersel for patients with low grade bladder cancer is safe and may be active against shedded and suspended tumor cells and thus may decrease recurrence risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with low grade TCC | Experimental | Drug: Hypertonic Saline 3%1. Patients of 18 years or older able to sign informed consent 2. A previous diagnosis of low grade bladder cancer 3. A pyelographic imaging examination (CTU, MRU, IVP, antegrade/retrograde pyelography) showing normal upper urinary tract in the 12 months prior to inclusion 4. Serum creatinine levels ≤ 2.0 mg/dl 5. Serum sodium levels <146 mg/ml 6. Current bladder tumor diagnosed by endoscopy or imaging in the last 3 months 7. Patient is candidate for TURBT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of 18 years or older able to sign informed consent
- A previous diagnosis of low grade bladder cancer
- A pyelographic imaging examination (CTU, MRU, IVP, antegrade/retrograde pyelography) showing normal upper urinary tract in the 12 months prior to inclusion
- Serum creatinine levels ≤ 2.0 mg/dl
- Serum sodium levels <146 mg/ml
Key exclusion criteria (5 listed)
- Previous history of high grade bladder cancer including carcinoma in situ
- Presence of upper urinary tract tumor on imaging
- Renal failure with serum creatinine >2.0 mg/dl prior to inclusion
- Hypernatremia >146 mg/dl prior to inclusion
- Contra-indication to undergo TURBT
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 |
|---|---|---|
| Hypertonic Saline 3%3% and 5% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. The pH may have been adjusted with hydrochloric acid. It contains no antimicrobial agents. | Drug | Patient with low grade TCC |
Primary outcome
Incidence of Treatment-Emergent Adverse Events as assessed by Common Terminology Criteriafor Adverse Events of Renal and urinary disorders (CTCAE)Version 5.0,2017, Satisfaction assessed by Clavien-Dindo.
Time frame: 12 month
The investigators monitored the Sodium levels in the blood after the administration of the Hypertonic Saline and documented and measure side effects by Clavien-Dindo scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for TCC
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hypertonic Saline 3% in people with TCC, run by Dan Leibovici at 1 site in Israel.
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 7 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: status not confirmed, as of the sponsor's last update on 4 Nov 2019. 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 Israel. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Incidence of Treatment-Emergent Adverse Events as assessed by Common Terminology Criteriafor Adverse Events of Renal and urinary disorders (CTCAE)Version 5.0,2017, Satisfaction assessed by Clavien-Dindo. (time frame: 12 month). 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 4 Nov 2019.