At a glance
ClinicalIndex Comparison RecordN/ACompleted· 20 enrolled
Drug / intervention
Allergen one-port tissue expander placement +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Clinical Trial Comparing 1-Port and 2-Port Tissue Expanders for Breast Reconstruction
In Brief
A clinical study evaluating Allergen one-port tissue expander placement and AlloX2 two-port tissue expander placement for Breast Cancer. Completed, enrolled 20 participants across 1 site.
Detailed Summary
Appropriate patients undergoing going immediate breast reconstruction with tissue expanders following mastectomy will be randomized to receive one-port or two-ports tissue expanders. Their clinical course, complications, and outcome will be analyzed.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartFeb 2016
First PostedApr 2016
Primary CompletionJul 2019
Study CompletionApr 2020
TodayJul 2026
First PostedApr 1, 2016
Enrollment StartFeb 1, 2016
Primary CompletionJul 19, 2019
Study CompletionApr 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 10.3 years ago
Interventions
Allergen one-port tissue expander placementdevice
patients will be randomized to receive a one port or two port tissue expander for breast reconstruction
AlloX2 two-port tissue expander placementdevice
patients will be randomized to receive a one port or two port tissue expander for breast reconstruction