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History of Changes for Study: NCT04064229
ivWatch SmartTouch Sensor: Device Validation for Infiltrated Tissues
Latest version (submitted May 31, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 20, 2019 None (earliest Version on record)
2 April 19, 2022
Quality Control Review has not concluded Returned: May 12, 2022
Arms and Interventions, Study Status, Study Identification, Document Section and Study Description
3 May 31, 2022 Baseline Characteristics, Outcome Measures, Study Status, Adverse Events, Participant Flow
Comparison Format:

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Study NCT04064229
Submitted Date:  August 20, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: IVW-CLR-CS27-400
Brief Title: ivWatch SmartTouch Sensor: Device Validation for Infiltrated Tissues
Official Title: ivWatch SmartTouch Sensor: Device Validation for Infiltrated Tissues
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2019
Overall Status: Completed
Study Start: April 3, 2019
Primary Completion: April 9, 2019 [Actual]
Study Completion: April 9, 2019 [Actual]
First Submitted: August 20, 2019
First Submitted that
Met QC Criteria:
August 20, 2019
First Posted: August 21, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
August 20, 2019
Last Update Posted: August 21, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: ivWatch, LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: A single arm trial consisting of 98 adult volunteers to assess the safety and efficacy of the ivWatch SmartTouch sensor in comparison to the ivWatch fiber optic sensor when observing infiltrated tissues at common sites for peripheral IV therapy.
Detailed Description:
Open or close this module Conditions
Conditions: Infiltration of Peripheral IV Therapy
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Diagnostic
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 99 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Infiltrated Tissue
The ivWatch Model 400 SmartTouch and fiber optic sensors monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.
Device: The ivWatch Model 400 with SmartTouch and fiber optic sensor
The ivWatch Model 400 with SmartTouch or fiber optic sensor monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Red Notification Sensitivity to Infiltrated Tissues
[ Time Frame: After each participant has been infiltrated, an expected average of 1 hour ]

The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.
Secondary Outcome Measures:
1. Yellow Notification Sensitivity to Infiltrated Tissues
[ Time Frame: After each participant has been infiltrated, an expected average of 1 hour ]

The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a yellow notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.
2. Infiltrated Volume When Red Notification Issued
[ Time Frame: After each participant has been infiltrated, an expected average of 1 hour ]

The amount of infiltrated isotonic saline solution when the red notification was issued by the ivWatch Model 400 device.
3. Infiltrated Volume When Yellow Notification Issued
[ Time Frame: After each participant has been infiltrated, an expected average of 1 hour ]

The amount of infiltrated isotonic saline solution when the yellow notification was issued by the ivWatch Model 400 device.
4. Significant Skin Irritation or Disruption to Skin Integrity
[ Time Frame: After each participant has been infiltrated, an expected average of 1 hour ]

The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Informed Consent
  • Pass health screen by clinician
  • 18 years or older

Exclusion Criteria:

  • Fail health screen
Open or close this module Contacts/Locations
Locations: United States, Virginia
ivWatch, LLC
Williamsburg, Virginia, United States, 23185
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services