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NCT01996917 · ClinicalTrials.gov registry record · NA

Use of Prineo in Breast Reduction Surgery

A NA study, sponsored by Columbia University.

Completed
Registry status
NA
Development phase
21
Enrollment target

NCT01996917: Completed NA study, sponsored by Columbia University.

NCT01996917 is a NA study that has completed, run by Columbia University. The registered enrollment target is 21 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.

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The verdict

NCT01996917, a NA study, has completed, sponsored by Columbia University.

COMPLETED
Registry status
NA
Development phase
21 participants
Enrollment target

Study Summary

This is a prospective, randomized, controlled, single-blinded study to compare Prineo™ with subcuticular sutures in 20 women undergoing bilateral breast reduction. For each patient, the final skin layer of one breast will be closed with subcuticular suture while the other breast will be closed with Prineo™. The treatment will be randomized to left or right breast. Therefore, the investigators will have 20 breasts in the suture group and 20 in the Prineo™ group, with each patient serving as her own control. For this study, the resident will close one side with suture and Dr. Rohde will apply the Prineo. The investigators will perform this study of incision closure under conditions as similar to normal conditions of closure.

Primary Outcome

This outcome measure looks at the operative time in seconds to closure of the final skin layer using Prineo or standard sutures.

Interventions

  • DEVICE Prineo

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2014-08
Est. Completion 2016-12
Phase NA
Columbia University

958 total trials

What the finished NCT01996917 record still lists

NCT01996917 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 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 1 intervention - of which Prineo is the first listed.

NCT01996917 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01996917 about?

NCT01996917 is a clinical study titled "Use of Prineo in Breast Reduction Surgery". This is a prospective, randomized, controlled, single-blinded study to compare Prineo™ with subcuticular sutures in 20 women undergoing bilateral breast reduction. For each patient, the final skin layer of one breast will be closed with subcuticular suture while the other breast will be closed with ...

What is the current status of trial NCT01996917?

This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2014-08. Estimated completion is 2016-12.

What interventions are being tested in trial NCT01996917?

The interventions under investigation include: Prineo (DEVICE).

Who is sponsoring clinical trial NCT01996917?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01996917's enrollment target sits among peer trials

21 1762nd of 2000 higher than 233 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 NCT01996917, the US trial registry maintained by the National Library of Medicine. NCT01996917 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.