Trial · NCT04846816
A Study to Assess Safety and Efficacy of a Novel Patch Infusor Device and Novel SUBCUTaneous Furosemide Formulation Combination in Patients With Heart Failure
NCT04846816, Phase 1, Completed, SQ Innovation, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess Safety and Efficacy of a Novel Patch Infusor Device and Novel SUBCUTaneous Furosemide Formulation Combination in Patients With Heart Failure. Trials, record NCT04846816. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04846816
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess Safety and Efficacy of a Novel Patch Infusor Device and Novel SUBCUTaneous Furosemide Formulation Combination in Patients With Heart Failure
- NCT number
- NCT04846816
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 20 participants, actual
- Lead sponsor
- SQ Innovation, Inc.
- Conditions
- Heart Failure
- Interventions
- SQIN-01
- First posted
- 2021-04-15
- Last updated
- 2026-04-24
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Investigate the Safety, Tolerability, Efficacy, and On-body Performance of a Novel Patch Infusor Device and Novel Furosemide Formulation Combination (SQIN-01) | 0-24 hours after infusion start | To investigate the safety, tolerability, efficacy, and on-body performance of a novel patch infusor device and novel furosemide formulation combination (SQIN-01). Safety as determined by treatment emergent adverse events (TEAEs), (including serious adverse events \[SAEs\]) and adverse drug events (ADEs) (including serious adverse drug events \[SADEs\]). |
| Primary | Infusion Site Pain | Baseline, 5 hours after infusion start, 24 hours after infusion start, and maximum pain during 5 hour infusion | Measured on a scale of 0 = no pain to 10 = maximal pain |
| Primary | Any Device Failures | During 5 hour infusion | Any device failures (eg, adhesive failure and drug delivery failure) |
| Primary | Plasma Furosemide Concentration | At baseline | Plasma furosemide concentration (at 0 min, pre-treatment) |
| Primary | Plasma Furosemide Concentration | At 60 minutes | Plasma furosemide concentration |
| Primary | Plasma Furosemide Concentration | At 240 minutes | Plasma furosemide concentration |
| Secondary | Urine Volume | 8 hours | Cumulative urine volume (ml) in urine collected over 8 hours from the start of SQIN-Furosemide infusion |
| Secondary | Sodium Concentration in Urine | 8 hours | Spot sodium concentration (mmol) in urine collected 8 hours after start of SQIN-Furosemide infusion |
| Secondary | Presence of Local Skin Reactions | Baseline, 5 hours post infusion start, and 24 hours post infusion start | Presence of local skin reactions on examination (Erythma/Edema Score: 0 = No skin response; ½ = Questionable or faint, indistinct erythema; 1 = Well-defined erythema; 2 = Erythema with slight to moderate edema; 3 = Vesicles (small blisters) or papules (small, circumscribed elevations); 4 = Bullous (large blister), spreading, or other severe reaction.) |
| Secondary | Patient Acceptability | 5 hours post infusion start | Patient acceptability using System Usability Scale - from 0 to 100 with a lower number correlating to poor usability and a higher number correlating to better usability by patients. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37804170 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04846816
GET https://conductscience.org/api/trials/v1/NCT04846816/registered