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Electrical Inhibition (EI): A Preliminary Study To Inhibit Preterm Labor And Preterm Birth

NCT02569216 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-11-09

No results posted yet for this study

Summary

An electrical-inhibition (EI) uterine pacemaker device similar to an electrical heart pacemaker delivers a weak electrical current to the human uterus during active preterm labor to rapidly and safely inhibit the unwanted premature uterine contractions and possibly a preterm birth.

Conditions

  • Premature Birth
  • Premature Labor

Interventions

DEVICE

Electrical Inhibition (EI)

constant direct current 1-20mA transvaginal 10 second bursts only when needed

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Karsdon, M.D. · New York University Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-09
Primary Completion
2016-08-15
Completion
2016-08-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02569216 on ClinicalTrials.gov