HealthyPhase 1NCT01051336
Safety and Tolerability Study of the Taris Placebo System
A Phase 1 study of Healthy, run by TARIS Biomedical, Inc. at 1 site in United States.
Trial summary
The aim of this protocol is to evaluate the tolerability of the Taris placebo system for the development program and to provide key safety and tolerability data for the Taris platform. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Nov 2009
- 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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female volunteers, 18 to 55 years of age
- Body weight >100 lbs and BMI (body mass index) within the range 18-30 kg/m2
- A score of less than 11 on the pelvic pain/urgency-frequency scale (PUF)
Who cannot join
- Presence of any bladder or urethra anatomical feature that, in the opinion of the investigator, might prevent the safe placement, indwelling use, or removal of the TARIS placebo system
- History of significant urogenital surgery (any type of bladder suspension, prolapse repair, incontinence procedure, or vaginal hysterectomy)
- History of kidney stone formation
- Chronic or recurring bacterial or viral infections of the urogenital system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Safety and Tolerability Study of the Taris Placebo System (A Novel Bladder Drug Delivery Platform)
The aim of this protocol is to evaluate the tolerability of the Taris placebo system for the development program and to provide key safety and tolerability data for the Taris platform.
- Conditions
- Healthy
- Being tested
- TARIS Placebo, Sham Procedure
- Keywords
- TARIS Placebo, Bladder, Interstitial Cystitis, Normal Healthy Volunteers
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TARIS PlaceboDevice
Sham ProcedureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| TARIS Placebo | Experimental | Not described Receives: Device: TARIS Placebo |
| Sham Procedure | Sham comparator | Not described Receives: Procedure: Sham Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, tolerability and retention of the TARIS placebo system upon insertion, 14-day exposure and removal
Measured: 14 days
Secondary outcomes (3)
Subject reported symptoms
Measured: 14 days
Routine and microscopic urinalysis
Measured: 14 days
Urine culture
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- TARIS Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pankaj M Jain, M.D., M.B.A., Principal investigator, Dedicated Phase I (Arizona Urology)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051336
- Sponsor's protocol ID
- TAR-100-101
- Status last verified
- Jan 2010
- First submitted
- 15 Jan 2010
- Last updated
- 18 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety and Tolerability Study of the Taris Placebo System (A Novel Bladder Drug Delivery Platform)
- ClinicalTrials.gov ID
- NCT01051336
- Acronym / sponsor ID
- TAR-100-101
- Conditions
- Healthy
- Keywords
- TARIS Placebo, Bladder, Interstitial Cystitis, Normal Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- TARIS Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 18 Jan 2010 (estimated)
- 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 aim of this protocol is to evaluate the tolerability of the Taris placebo system for the development program and to provide key safety and tolerability data for the Taris platform.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TARIS Placebo | Experimental | Device: TARIS Placebo |
| Sham Procedure | Sham comparator | Procedure: Sham Procedure |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy female volunteers, 18 to 55 years of age
- Body weight >100 lbs and BMI (body mass index) within the range 18-30 kg/m2
- A score of less than 11 on the pelvic pain/urgency-frequency scale (PUF)
Key exclusion criteria (4 listed)
- Presence of any bladder or urethra anatomical feature that, in the opinion of the investigator, might prevent the safe placement, indwelling use, or removal of the TARIS placebo system
- History of significant urogenital surgery (any type of bladder suspension, prolapse repair, incontinence procedure, or vaginal hysterectomy)
- History of kidney stone formation
- Chronic or recurring bacterial or viral infections of the urogenital system
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 |
|---|---|---|
| TARIS Placebo | Device | TARIS Placebo |
| Sham Procedure | Procedure or surgery | Sham Procedure |
Primary outcome
Safety, tolerability and retention of the TARIS placebo system upon insertion, 14-day exposure and removal
Time frame: 14 days
3 secondary outcomes
Subject reported symptoms
Time frame: 14 days
Routine and microscopic urinalysis
Time frame: 14 days
Urine culture
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2010.
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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.
Pankaj M Jain, M.D., M.B.A. principal investigator
Dedicated Phase I (Arizona Urology)
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 of Healthy, run by TARIS Biomedical, Inc. at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 18 Jan 2010. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety, tolerability and retention of the TARIS placebo system upon insertion, 14-day exposure and removal (time frame: 14 days). 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 18 Jan 2010.