Ignite Creation Date:
2024-05-06 @ 12:42 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03823027
Status:
COMPLETED
Last Update Posted:
2019-11-05
First Post:
2019-01-28
Brief Title:
STAR Study Investigating Performance and Safety of the Medical Device SiPore15
Sponsor:
Sigrid Therapeutics AB
Organization:
Sigrid Therapeutics AB
Study Overview
Official Title:
Open-label Single-arm Multicenter Study Investigating Performance and Safety of SiPore15 in Obese and Overweight Subjects With Prediabetes or Newly Diagnosed Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2019-11
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:
None
Brief Summary:
The primary objective of STAR01 is to evaluate the performance and safety of the medical device class IIb SiPore15 after a 12-week long treatment in the target population of obese and overweight subjects with prediabetes or newly diagnosed type 2 diabetes The expected performance and safety of the device is based on the safety and efficacy results seen in an earlier First-in-Man FIM study The safety and tolerability of SiPore15 is based on the well-established and extensive use of food grade silicon dioxide and favorable data from the FIM study Data on side-effects will be collected for verification of device safety The study duration is 24 weeks in total 12 weeks from baseline on investigational medicinal device IMD treatment with additional 12 weeks off treatment The study population is planned for forty 40 subjects to be enrolled male and females age 18 years and fulfilling all inclusion criteria but none of the exclusion criteria
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None