Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-13 @ 6:11 PM
Study NCT ID:
NCT03819634
Status:
COMPLETED
Last Update Posted:
2021-05-25
First Post:
2019-01-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Longevity of Multi-Slitted Catheter With Lantern Technology
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Longevity of Multi-Slitted Catheter, the Convatec Inset II With Lantern Technology
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Lantern
Brief Summary:
To determine time to set failure when the Convatec Inset II with Lantern technology (Convatec Lantern) infusion set with multi-slitted catheter is worn for up to 10 days
Detailed Description:
This is a pilot study to obtain preliminary data to determine the time to set failure when the Lantern infusion set is worn for up to 10 days. The study is not intended for registration purposes or to support a 510(k) submission. The study will be conducted at one site: Stanford University.
This study will enroll 24 subjects (as per FDA approval) to establish the maximum length of Lantern infusion set wear when 80% of sets are still functional (excluding accidental "pull-outs"). Each participant will place the set and wear it for 10 days or until set failure and data will be collected on the cause of set failure. If a set is accidentally pulled out, it can be replaced by the subject. Failures are based on:
1. Presence of serum ketones with hyperglycemia
2. Unexplained hyperglycemia
3. Signs of infection at the infusion site
4. Pump occlusion alarm
5. Adhesive failure
Since infusion set failures will occur after variable lengths of wear, regularly scheduled visits are unlikely to capture the day of an infusion set failure. Instead the subject will be taught how to insert the set, measure erythema and induration with a ruler marked in millimeters and to take a picture of the infusion site. Subjects will be instructed to text the study team when they remove their infusion set and to send a picture of the infusion site and measurements. If there is any evidence of an infection (≥10 mm of erythema or induration), they will be asked to come in that day for an unscheduled visit.
This study will enroll 24 subjects (as per FDA approval) to establish the maximum length of Lantern infusion set wear when 80% of sets are still functional (excluding accidental "pull-outs"). Each participant will place the set and wear it for 10 days or until set failure and data will be collected on the cause of set failure. If a set is accidentally pulled out, it can be replaced by the subject. Failures are based on:
1. Presence of serum ketones with hyperglycemia
2. Unexplained hyperglycemia
3. Signs of infection at the infusion site
4. Pump occlusion alarm
5. Adhesive failure
Since infusion set failures will occur after variable lengths of wear, regularly scheduled visits are unlikely to capture the day of an infusion set failure. Instead the subject will be taught how to insert the set, measure erythema and induration with a ruler marked in millimeters and to take a picture of the infusion site. Subjects will be instructed to text the study team when they remove their infusion set and to send a picture of the infusion site and measurements. If there is any evidence of an infection (≥10 mm of erythema or induration), they will be asked to come in that day for an unscheduled visit.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: