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ivWatch Sensor: Device Validation for Infiltrated Tissues

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ClinicalTrials.gov Identifier: NCT04064229
Recruitment Status : Completed
First Posted : August 21, 2019
Results First Posted : June 24, 2022
Last Update Posted : June 24, 2022
Sponsor:
Information provided by (Responsible Party):
ivWatch, LLC

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Infiltration of Peripheral IV Therapy
Interventions Device: ivWatch Model 400 with SmartTouch Sensor
Device: ivWatch Model 400 with Fiber Optic Sensor
Enrollment 99
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Infiltrated Tissue
Hide Arm/Group Description

The ivWatch Model 400 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.

ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.

Period Title: Overall Study
Number of participants Number of units (IV site)
Started 99 198
Completed 99 198
Not Completed 0 0
Arm/Group Title Infiltrated Tissue
Hide Arm/Group Description

The ivWatch Model 400 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.

ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.

Overall Number of Baseline Participants 98
Overall Number of Units Analyzed
Type of Units Analyzed: IV Site
196
Hide Baseline Analysis Population Description
One case study (participant) was rejected and removed from analysis because there was a protocol error where the IV tubing was not properly connected, and the saline was leaked from the tubing rather than injected at the skin site.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants
<=18 years
0
   0.0%
Between 18 and 65 years
92
  93.9%
>=65 years
6
   6.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants
41.1  (15.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants
Female
62
  63.3%
Male
36
  36.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Skin Pigmentation   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 98 participants
1.76  (0.84)
[1]
Measure Description: Skin pigmentation was scored from 1 to 3 where 1 represents light skin pigmentation, 2 represents medium skin pigmentation, and 3 represents dark skin pigmentation.
Body Mass Index (BMI)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants
Normal (BMI 18.5 to < 25)
22
  22.4%
Overweight (BMI 25 to < 30)
29
  29.6%
Obese (BMI >= 30)
47
  48.0%
[1]
Measure Description: BMI = 703 * weight (lb.) / (height (in.)^2)
1.Primary Outcome
Title Red Notification Sensitivity to Infiltrated Tissues
Hide Description 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.
Time Frame After each participant has been infiltrated, an expected average of 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SmartTouch Sensor Fiber Optic Sensor
Hide Arm/Group Description:
ivWatch Model 400 with SmartTouch sensor used to monitor IV site
ivWatch Model 400 with Fiber Optic sensor used to monitor IV site
Overall Number of Participants Analyzed 98 98
Overall Number of Units Analyzed
Type of Units Analyzed: IV Site
98 98
Mean (95% Confidence Interval)
Unit of Measure: percentage of infiltrations detected
99.0
(94.5 to 100.0)
99.0
(94.5 to 100.0)
2.Secondary Outcome
Title Yellow Notification Sensitivity to Infiltrated Tissues
Hide Description 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.
Time Frame After each participant has been infiltrated, an expected average of 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SmartTouch Sensor Fiber Optic Sensor
Hide Arm/Group Description:
ivWatch Model 400 with SmartTouch sensor used to monitor IV site
ivWatch Model 400 with Fiber Optic sensor used to monitor IV site
Overall Number of Participants Analyzed 98 98
Overall Number of Units Analyzed
Type of Units Analyzed: IV SIte
98 98
Mean (95% Confidence Interval)
Unit of Measure: percentage of infiltrations detected
99.0
(94.5 to 100.0)
99.0
(94.5 to 100.0)
3.Secondary Outcome
Title Infiltrated Volume When Red Notification Issued
Hide Description The amount of infiltrated isotonic saline solution when the red notification was issued by the ivWatch Model 400 device.
Time Frame After each participant has been infiltrated, an expected average of 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SmartTouch Sensor Fiber Optic Sensor
Hide Arm/Group Description:
ivWatch Model 400 with SmartTouch sensor used to monitor IV site
ivWatch Model 400 with Fiber Optic sensor used to monitor IV site
Overall Number of Participants Analyzed 98 98
Overall Number of Units Analyzed
Type of Units Analyzed: IV Site
98 98
Median (Standard Deviation)
Unit of Measure: mL
1.75  (1.45) 4.33  (2.11)
4.Secondary Outcome
Title Infiltrated Volume When Yellow Notification Issued
Hide Description The amount of infiltrated isotonic saline solution when the yellow notification was issued by the ivWatch Model 400 device.
Time Frame After each participant has been infiltrated, an expected average of 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SmartTouch Sensor Fiber Optic Sensor
Hide Arm/Group Description:
ivWatch Model 400 with SmartTouch sensor used to monitor IV site
ivWatch Model 400 with Fiber Optic sensor used to monitor IV site
Overall Number of Participants Analyzed 98 98
Overall Number of Units Analyzed
Type of Units Analyzed: IV Site
98 98
Median (Standard Deviation)
Unit of Measure: mL
1.66  (1.39) 3.90  (1.89)
5.Secondary Outcome
Title Significant Skin Irritation or Disruption to Skin Integrity
Hide Description The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study.
Time Frame After each participant has been infiltrated, an expected average of 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SmartTouch Sensor Fiber Optic Sensor
Hide Arm/Group Description:
ivWatch Model 400 with SmartTouch sensor used to monitor IV site
ivWatch Model 400 with Fiber Optic sensor used to monitor IV site
Overall Number of Participants Analyzed 98 98
Overall Number of Units Analyzed
Type of Units Analyzed: IV Site
98 98
Count of Units
Unit of Measure: IV Site
0
   0.0%
0
   0.0%
Time Frame A visual assessment of the skin was performed after completing each study. In addition, photos of the skin were captured before and after the study. The time frame of assessment was an expected average of 1 hour after each participant has been infiltrated.
Adverse Event Reporting Description Serious and other (non-serious) adverse events were assessed by the clinician performing the study.
 
Arm/Group Title SmartTouch Sensor Fiber Optic Sensor
Hide Arm/Group Description ivWatch Model 400 with SmartTouch sensor used to monitor IV site ivWatch Model 400 with Fiber Optic sensor used to monitor IV site
All-Cause Mortality
SmartTouch Sensor Fiber Optic Sensor
Affected / at Risk (%) Affected / at Risk (%)
Total   0/99 (0.00%)   0/99 (0.00%) 
Hide Serious Adverse Events
SmartTouch Sensor Fiber Optic Sensor
Affected / at Risk (%) Affected / at Risk (%)
Total   0/99 (0.00%)   0/99 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SmartTouch Sensor Fiber Optic Sensor
Affected / at Risk (%) Affected / at Risk (%)
Total   0/99 (0.00%)   0/99 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jason Naramore
Organization: ivWatch, LLC
Phone: 1-855-489-2824 ext 7019
EMail: jason.naramore@ivwatch.com
Layout table for additonal information
Responsible Party: ivWatch, LLC
ClinicalTrials.gov Identifier: NCT04064229    
Other Study ID Numbers: IVW-CLR-CS27-400
First Submitted: August 20, 2019
First Posted: August 21, 2019
Results First Submitted: April 19, 2022
Results First Posted: June 24, 2022
Last Update Posted: June 24, 2022