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NCT02390661 · ClinicalTrials.gov registry record · NA

Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal

A NA study, sponsored by Michigan State University.

Completed
Registry status
NA
Development phase
37
Enrollment target

NCT02390661: Completed NA study, sponsored by Michigan State University.

NCT02390661 is a NA study that has completed, run by Michigan State University. The registered enrollment target is 37 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02390661, a NA study, has completed, sponsored by Michigan State University.

COMPLETED
Registry status
NA
Development phase
37 participants
Enrollment target

Study Summary

The proposed study is randomised controlled trial where informed and consenting patients who have a Mammosite/SAVI device placed, are randomized into two groups: a control group that has the device removed in the traditional manner without having a drain placed, and an experimental group that will have a penrose drain placed under sterile conditions at the time of removal of their device. The drain will be placed in the same site used for the APBI device and no additional surgery will be performed. The drain will remain for 2-3 days and it will be removed by the patient at home. They will return for their routine follow-up appointments and be monitored for development of a seroma with the use of standard ultrasound and physical exam. Hypothesis: Based on the null hypothesis there will be no difference in the rate of seroma formation after the APBI device removal if a drain is placed.

Primary Outcome

The patient will be evaluated by physical exam and ultrasound of the affected breast.

Interventions

  • DEVICE Penrose drain placement

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2013-11
Est. Completion 2017-11
Phase NA
Michigan State University

120 total trials

What the finished NCT02390661 record still lists

NCT02390661 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Penrose drain placement is the first listed.

NCT02390661 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02390661 about?

NCT02390661 is a clinical study titled "Drain Placement for Seroma Prevention After Mammosite/SAVI Catheter Removal". The proposed study is randomised controlled trial where informed and consenting patients who have a Mammosite/SAVI device placed, are randomized into two groups: a control group that has the device removed in the traditional manner without having a drain placed, and an experimental group that will h...

What is the current status of trial NCT02390661?

This trial is currently completed. It is a NA study. The enrollment target is 37 participants. The study started on 2013-11. Estimated completion is 2017-11.

What interventions are being tested in trial NCT02390661?

The interventions under investigation include: Penrose drain placement (DEVICE).

Who is sponsoring clinical trial NCT02390661?

This trial is sponsored by Michigan State University, which has 120 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02390661's enrollment target sits among peer trials

37 1540th of 2000 higher than 460 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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Source: ClinicalTrials.gov NCT02390661, the US trial registry maintained by the National Library of Medicine. NCT02390661 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.