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)

NCT04836572 | Completed

• 1 other identifier: SQI-09-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Volunteer Study

Keywords

Adhesive; Attachment duarability; Assess possible skin reactions; Erythema; Edema

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  > 5 hours

Secondary Outcomes (3)

• Comfort of Wear

  5-12 hours

• Interference

  5-12 hours

• Irritation

  5-12 hours

Study Arms (1)

Wear Period

OTHER

Other: 3M 1529 Adhesive Tape

Interventions

3M 1529 Adhesive Tape OTHER

5-12 hour adhesive wear

Wear Period

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• SQ Innovation, Inc.: lead
• Community Clinical Research Network: collaborator

Study Sites (1)

Community Clinical Research Network

Marlborough, Massachusetts, 01752, United States

Location

MeSH Terms

Conditions

Erythema; Edema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kyle Magner, RN

  Community Clinical Research Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 8, 2021
• Study Start: January 20, 2021
• Primary Completion: March 4, 2021
• Study Completion: March 4, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

US (1)