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NCT01544335 · ClinicalTrials.gov registry record
Evaluation of BIS for Quantification of Lymphedema
A clinical trial of Breast Cancer, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- 270
- Enrollment target
- 1
- Study location
NCT01544335: Completed study of Breast Cancer, sponsored by Massachusetts General Hospital.
NCT01544335 is a study of Breast Cancer that has completed, run by Massachusetts General Hospital. The registered enrollment target is 270 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01544335, a study of Breast Cancer, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- 270 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine whether measuring the fluid in your arms using Bioimpedance Spectroscopy is as effective at detecting and monitoring lymphedema as measurements with the Perometer. The investigators will also evaluate any symptoms you may experience in your arms during and after treatment for breast cancer with a questionnaire.
Primary Outcome
Correlation of volumetric measurements obtained using Perometry with impedance ratios obtained through BIS at the baseline examination and during follow-up visits. Impedance ratios will also be correlated with symptoms indicated in the LEFT-BC questionnaires completed during each examination. Volumetric arm measurements from perometry will be quantified using the RVC formula, which will be compared with impedance ratios calculated using the BIS device software.
Conditions Studied
Interventions
- OTHER Bioimpedance Spectroscopy
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2011-12 |
| Est. Completion | 2020-09 |
What the finished NCT01544335 record still lists
NCT01544335 is an observational study that tracks outcomes without assigning an intervention. The registered 270 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Bioimpedance Spectroscopy is the first listed.
NCT01544335 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01544335 about?
NCT01544335 is a clinical study titled "Evaluation of BIS for Quantification of Lymphedema". The purpose of this study is to determine whether measuring the fluid in your arms using Bioimpedance Spectroscopy is as effective at detecting and monitoring lymphedema as measurements with the Perometer. The investigators will also evaluate any symptoms you may experience in your arms during and a...
What is the current status of trial NCT01544335?
This trial is currently completed. The enrollment target is 270 participants. The study started on 2011-12. Estimated completion is 2020-09.
What conditions does trial NCT01544335 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT01544335?
The interventions under investigation include: Bioimpedance Spectroscopy (OTHER).
Who is sponsoring clinical trial NCT01544335?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01544335 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01544335's enrollment target sits among peer trials
270 304th of 1224 higher than 918 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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