CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 480 enrolled
Drug / intervention
MILTA Device +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.

Search/NCT04896034
NCT04896034N/ACompleted
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Evaluation of the Efficacy of the Photobiomodulation on the Pelvi-perineal Pain in Patients in Immediate Post-partum Situation

Elsan·interventional·Posted May 21, 2021·Updated Feb 29, 2024

In Brief

A clinical study evaluating MILTA Device and " control 1 " fake MILTA device for Pelvic Pain. Completed, enrolled 480 participants across 1 site.

Detailed Summary

Photobiomodulation (PBM), evaluated in this study, will be delivered by a CE marked class IIa medical device (MILTA technology), composed of a panel that gathers 18 emitters. This is an innovative, alternative, soft technology, based on a cross action of LED light emission, a low intensity nanopulsed laser and a magnetic tunnel. The sessions last 10 minutes each, in total in the study two sessions will be delivered.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPelvic Pain
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 21, 2021
Enrollment StartMay 6, 2021
Primary CompletionApr 30, 2023
Study CompletionMay 12, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.1 years ago

Interventions

MILTA Devicedevice

Patients in MILTA Device group will each receive 2 sessions of PBM in this study, the first session within 24 hours of delivery, and the second session 24 hours after the first session.

" control 1 " fake MILTA devicedevice

Patients in group control 1 will each receive 2 sessions of PBM in this study, the first session within 24 hours of delivery, and the second session 24 hours after the first session.