Sinus PainNCT03888274
ClearUP Longitudinal Pilot Study
A study testing ClearUP Sinus Pain Relief in people with Sinus Pain and Congestion, run by Tivic Health Systems at 1 site in United States.
Trial summary
Single arm, open label pilot study assessing the longitudinal home use of ClearUp Sinus Pain Relief for four weeks. Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- Sinus Pain, Congestion
- What is being tested?
- ClearUP Sinus Pain Relief
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2018to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-71 years of age (inclusive)
- Present with symptoms of sinus pain or facial pain in the forehead, periorbital, facial, or nasal region
- Current pain score ≥ 5 (Numeric Rating Scale 0-10)
- Frequency of sinus/facial pain at least twice weekly for 1 month
- Able to read and understand English
- Agree to participate in the study
- Able and willing to provide Informed Consent
Who cannot join
- Do not meet Inclusion Criteria
- Currently taking or recently taken any oral steroid medications in the last 90 days
- Sinus surgery in previous 90 days
- History of Chronic Migraine (≥ 15 headache days per month)
- Pain location in the vertex, occiput, or temporal region of the skull or in mandibular region
- Purulent rhinorrhea
Trial locations and contacts
1 site in 1 country.
United States1 site
Allergy and Asthma Associates of Santa Clara Valley Research Center
San Jose, California, 95117
About this study
Single arm, open label pilot study assessing the longitudinal home use of ClearUp Sinus Pain Relief for four weeks.
- Conditions
- Sinus Pain, Congestion
- Being tested
- ClearUP Sinus Pain Relief
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearUP Sinus Pain ReliefDevice
Microcurrent Device Treatment
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Device: ClearUP Sinus Pain Relief |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale for Pain
Change in Numeric Rating Scale for Pain from Baseline to Four Weeks. Scale range 0, no pain, to 10 severe pain.
Measured: 4 weeks
Secondary outcomes (2)
Congestion Quantifier 7
Change in Congestion Quantifier 7 from Baseline to Four Weeks. Congestion Quantifier 7 is a 7 item questionnaire that quantifies congestion symptom severity. It is scored from 0 (no congestion symptoms) to 28 (severe congestions symptoms).
Measured: 4 Weeks
Numeric Rating Scale for Pain
Acute Change in Numeric Rating Scale for Pain from Baseline to 6 Hours. Scale range 0, no pain, to 10 severe pain.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start29 Nov 2018
- Primary completion13 Feb 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sinus PainStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tivic Health Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888274
- Sponsor's protocol ID
- CP00003
- Status last verified
- Mar 2020
- First submitted
- 21 Mar 2019
- Last updated
- 2 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Goldsobel AB, Prabhakar N, Gurfein BT. Prospective trial examining safety and efficacy of microcurrent stimulation for the treatment of sinus pain and congestion. Bioelectron Med. 2019 Nov 20;5:18. doi: 10.1186/s42234-019-0035-x. eCollection 2019.
PubMed 32232107
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ClearUP Longitudinal Pilot Study
- ClinicalTrials.gov ID
- NCT03888274
- Acronym / sponsor ID
- CP00003
- Conditions
- Sinus Pain, Congestion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tivic Health SystemsIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Posted 2 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single arm, open label pilot study assessing the longitudinal home use of ClearUp Sinus Pain Relief for four weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: ClearUP Sinus Pain Relief |
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-71 years of age (inclusive)
- Present with symptoms of sinus pain or facial pain in the forehead, periorbital, facial, or nasal region
- Current pain score ≥ 5 (Numeric Rating Scale 0-10)
- Frequency of sinus/facial pain at least twice weekly for 1 month
- Able to read and understand English
Key exclusion criteria (6 listed)
- Do not meet Inclusion Criteria
- Currently taking or recently taken any oral steroid medications in the last 90 days
- Sinus surgery in previous 90 days
- History of Chronic Migraine (≥ 15 headache days per month)
- Pain location in the vertex, occiput, or temporal region of the skull or in mandibular region
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 |
|---|---|---|
| ClearUP Sinus Pain ReliefMicrocurrent Device Treatment | Device | Active |
Primary outcome
Numeric Rating Scale for Pain
Time frame: 4 weeks
Change in Numeric Rating Scale for Pain from Baseline to Four Weeks. Scale range 0, no pain, to 10 severe pain.
2 secondary outcomes
Congestion Quantifier 7
Time frame: 4 Weeks
Numeric Rating Scale for Pain
Time frame: 6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32232107Goldsobel AB, Prabhakar N, Gurfein BT. Prospective trial examining safety and efficacy of microcurrent stimulation for the treatment of sinus pain and congestion. Bioelectron Med. 2019 Nov 20;5:18. doi: 10.1186/s42234-019-0035-x. eCollection 2019.
- 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.
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 study testing ClearUP Sinus Pain Relief in people with Sinus Pain and Congestion, run by Tivic Health Systems 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 7 inclusion and 6 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 2 Apr 2020. 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. 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?
Yes. Results are posted in the registry (first posted 2 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Numeric Rating Scale for Pain (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03888274, which also lists 1 linked publication.
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 2 Apr 2020.