Healthy Volunteer StudyNCT04836572
An Open-label, Non Significant Risk, Adhesive Wear Validation Study for the On Body Drug Delivery Device Component of the SQIN-01 Furosemide Infusor (Infusor Device)
A study testing 3M 1529 Adhesive Tape in people with Healthy Volunteer Study, run by SQ Innovation, Inc. at 1 site in United States.
Trial summary
The purpose of the present study is to test the adequacy, performance and skin reactivity of the adhesive tape to be utilized in the to-be-marketed Device. The present study will examine adhesive hold performance, re-use protection (i.e. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- 3M 1529 Adhesive Tape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2021to 4 Mar 2021
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be considered for inclusion only if they meet all of the following criteria:
- An Institutional Review Board (IRB)-approved informed consent is signed and dated prior to any study-related activities.
- Male and female subjects ≥40 and ≤80 years of age
- Body mass index (BMI) <38 kg/m2.
- Females will be non-pregnant and non-lactating.
- Able to participate in the study in the opinion of the Investigator.
- Has the ability to understand the requirements of the study and is willing to comply with all study procedures.
Who cannot join
- Subjects will be excluded from participation if they meet any of the following criteria:
- Systolic blood pressure (SBP) <90 mmHg.
- Temperature ≥38°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment.
- History of COVID-19 infection or recent exposure to someone with COVID-19 or who is currently in quarantine for COVID-19 exposure.
- Presence of signs or symptoms of possible COVID-19 infection, including cough, shortness of breath, or temperature ≥ 38°C.
- Previous abdominal surgery resulting in presence of a scar or malformation in upper abdominal area.
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- Presence of skin disorder or abnormality in upper abdominal area.
- Known or suspected allergy to acylate adhesives or other materials present in the device.
- Significant comorbidities or health issues which in the opinion of the investigator may interfere with study participation or study assessments.
- Major surgery within 30 days prior to Screening.
- Administration of an investigational drug or implantation of investigational device, or participation in another interventional trial, within 30 days prior to Screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Clinical Research Network
Marlborough, Massachusetts, 01752
About this study
The purpose of the present study is to test the adequacy, performance and skin reactivity of the adhesive tape to be utilized in the to-be-marketed Device.
The present study will examine adhesive hold performance, re-use protection (i.e. adhesive re-application) and skin reactivity/tolerability of the proposed commercial adhesive tape (i.e. within the Test Infusor Device; TID). As the purpose of the study is to assess adhesive performance which does not require activation of the device. Hence in this study no canula will be deployed (no skin penetration) and no delivery of the drug or other fluids.
Read the detailed description
An open-label, non significant risk, adhesive wear validation study with 60 adult subjects.
Group A (30 subjects): Wearing of the Infusor for 5-9hrs followed by assessment and subsequent removal of the Infusor by study staff with photographic recording prior to and after removal.
Group B (30 subjects): Wearing of the Infusor for 5-9hrs followed by assessment and photographic recording of the Infusor by study staff after which the subject will return home and removal of the Infusor by subject or caregiver approximately 12hrs after placement (± 1hr), when another photograph will be taken. The subject must return the device to the site and transfer the photograph in accordance with the instructions.
Until enrollment for Group B is complete, study candidates will be asked if prefer group A or B. Additional inclusion criteria apply for participation in group B.
Consent, screening and enrollment may be performed on the same day (Day 1) Screening must be performed within 7 days of the Wear phase.
Following signing of the ICF (A or B) each subject will complete Screening activities (height, weight, brief medical history). If the subject meets all inclusion criteria an none of the exclusion criteria the subject may enroll.
The Wear Phase consists of one (1) wear period of five to twelve (5-12) hours.
- Conditions
- Healthy Volunteer Study
- Being tested
- 3M 1529 Adhesive Tape
- Keywords
- Adhesive, Attachment duarability, Assess possible skin reactions, Erythema, Edema
- Medical subject headings
- Erythema, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M 1529 Adhesive TapeOther
5-12 hour adhesive wear
| Study group | Role | What they receive |
|---|---|---|
| Wear Period | Other | Not described Receives: Other: 3M 1529 Adhesive Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhesion
Number of participants with failed adhesion (Adhesion Score of 3 or 4 - Appendix A) 5-9 hours after placement as determined by study staff and documented by photography.
Measured: 5-9 hours
Re-adhesion
Number of participants with successful re-adhesion - score of 0, 1 or 2 as per Appendix A at 5 minutes after adhesion at the opposite side of the upper abdomen after a completed simulated wear period of no less than 5 hours
Measured: > 5 hours
Secondary outcomes (3)
Comfort of Wear
Overall average comfort of wear score of the test device using a 10-point Visual Analogue Scale (VAS). The scores are values 0-10, with 0 being very comfortable, and 10 being intolerable discomfort.
Measured: 5-12 hours
Interference
Overall average scoring of interference with important routine activities of daily living such as use of the bathroom, walking, and climbing stairs using a 10-point Visual Analogue Scale (VAS). The scores are values are 0-10, with 0 being no interference, and 10 being great interference.
Measured: 5-12 hours
Irritation
Overall average irritation score for erythema and edema (on a 5-point scale) after wear(Appendix C). The scores are values 0-4 with 0 being no erythema/edema, and 4 being severe erythema/edema.
Measured: 5-12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start20 Jan 2021
- Primary completion4 Mar 2021
- Study completion4 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer StudyStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- SQ Innovation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Community Clinical Research Network
- Responsible party
- Sponsor
- Investigators
- Kyle Magner, RN, Principal investigator, Community Clinical Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836572
- Sponsor's protocol ID
- SQI-09-01
- Status last verified
- Jul 2021
- First submitted
- 31 Mar 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non Significant Risk, Adhesive Wear Validation Study for the On Body Drug Delivery Device Component of the SQIN-01 Furosemide Infusor (Infusor Device)
- ClinicalTrials.gov ID
- NCT04836572
- Acronym / sponsor ID
- SQI-09-01
- Conditions
- Healthy Volunteer Study
- Keywords
- Adhesive, Attachment duarability, Assess possible skin reactions, Erythema, Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- SQ Innovation, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Community Clinical Research Network
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 4 Mar 2021 (actual)
- First posted
- 8 Apr 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.
The purpose of the present study is to test the adequacy, performance and skin reactivity of the adhesive tape to be utilized in the to-be-marketed Device.
The present study will examine adhesive hold performance, re-use protection (i.e. adhesive re-application) and skin reactivity/tolerability of the proposed commercial adhesive tape (i.e. within the Test Infusor Device; TID). As the purpose of the study is to assess adhesive performance which does not require activation of the device. Hence in this study no canula will be deployed (no skin penetration) and no delivery of the drug or other fluids.
Detailed description
An open-label, non significant risk, adhesive wear validation study with 60 adult subjects.
Group A (30 subjects): Wearing of the Infusor for 5-9hrs followed by assessment and subsequent removal of the Infusor by study staff with photographic recording prior to and after removal.
Group B (30 subjects): Wearing of the Infusor for 5-9hrs followed by assessment and photographic recording of the Infusor by study staff after which the subject will return home and removal of the Infusor by subject or caregiver approximately 12hrs after placement (± 1hr), when another photograph will be taken. The subject must return the device to the site and transfer the photograph in accordance with the instructions.
Until enrollment for Group B is complete, study candidates will be asked if prefer group A or B. Additional inclusion criteria apply for participation in group B.
Consent, screening and enrollment may be performed on the same day (Day 1) Screening must be performed within 7 days of the Wear phase.
Following signing of the ICF (A or B) each subject will complete Screening activities (height, weight, brief medical history). If the subject meets all inclusion criteria an none of the exclusion criteria the subject may enroll.
The Wear Phase consists of one (1) wear period of five to twelve (5-12) hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wear Period | Other | Other: 3M 1529 Adhesive Tape |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects will be considered for inclusion only if they meet all of the following criteria:
Key exclusion criteria (11 listed)
- Subjects will be excluded from participation if they meet any of the following criteria:
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 |
|---|---|---|
| 3M 1529 Adhesive Tape5-12 hour adhesive wear | Other | Wear Period |
Primary outcome
Adhesion
Time frame: 5-9 hours
Number of participants with failed adhesion (Adhesion Score of 3 or 4 - Appendix A) 5-9 hours after placement as determined by study staff and documented by photography.
Re-adhesion
Time frame: > 5 hours
Number of participants with successful re-adhesion - score of 0, 1 or 2 as per Appendix A at 5 minutes after adhesion at the opposite side of the upper abdomen after a completed simulated wear period of no less than 5 hours
3 secondary outcomes
Comfort of Wear
Time frame: 5-12 hours
Interference
Time frame: 5-12 hours
Irritation
Time frame: 5-12 hours
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 21 Jul 2021.
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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.
Kyle Magner, RN principal investigator
Community Clinical Research Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3M 1529 Adhesive Tape in people with Healthy Volunteer Study, run by SQ Innovation, 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 7 inclusion and 11 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 21 Jul 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 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?
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?
Adhesion (time frame: 5-9 hours). The study lists 2 primary outcomes in all. 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 21 Jul 2021.