One-Year Follow-up Safety Study in Subjects Previously Implanted With VC-01™

A One-Year, Multicenter, Observational, Follow-up Safety Study in Subjects Previously Implanted With VC-01™ Combination Product

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02939118

Enrollment

Registered

2016-10-19

Start date

2016-11-07

Completion date

2024-02-08

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Brief summary

The purpose of this trial is to evaluate the long-term safety in subjects previously implanted with VC-01™ combination product.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Previous implantation of VC-01™ combination product with subsequent explantation of all VC-01 units.

Exclusion criteria

* There are no

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events reported during the study.	12 months

Outcome results