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NCT03657069 · ClinicalTrials.gov registry record · NA
Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy
A NA study, sponsored by Stanford University.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT03657069: Completed NA study, sponsored by Stanford University.
NCT03657069 is a NA study that has completed, run by Stanford University. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03657069, a NA study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
This phase 1 trial studies how well Blossom Smart Expander Technology works in breast reconstruction in participants with breast cancer undergoing mastectomy. Blossom Smart Expander Technology allows for slow and continuous injection of small amounts of saline, from an external pouch and based on precise pressure and volume measurements, into breast expander implants. It may help in achieving the same reconstructive goals as conventional tissue expansion in a shorter period of time and while avoiding frequent injections through the skin, which cause patient discomfort and require many clinic visits.
Primary Outcome
Measured by calculating the number of days from expander placement to achievement of desired expansion volume. Data were collected on a weekly basis until completion of breast expansion along with stabilization of surgical scars and percutaneous drain removal.
Interventions
- DEVICE Blossom
- OTHER Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-08-01 |
| Est. Completion | 2020-08-19 |
| Phase | NA |
What the finished NCT03657069 record still lists
NCT03657069 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Blossom is the first listed.
NCT03657069 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03657069 about?
NCT03657069 is a clinical study titled "Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy". This phase 1 trial studies how well Blossom Smart Expander Technology works in breast reconstruction in participants with breast cancer undergoing mastectomy. Blossom Smart Expander Technology allows for slow and continuous injection of small amounts of saline, from an external pouch and based on pr...
What is the current status of trial NCT03657069?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2018-08-01. Estimated completion is 2020-08-19.
What interventions are being tested in trial NCT03657069?
The interventions under investigation include: Blossom (DEVICE), Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire (OTHER).
Who is sponsoring clinical trial NCT03657069?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03657069's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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