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NCT01220011 · ClinicalTrials.gov registry record · NA

Randomized Controlled Trial Comparing a Conservative Management and Laser Surgery

A NA study of Infant, Newborn, Diseases and Hematologic Disease, sponsored by Assistance Publique - Hôpitaux de Paris.

Completed
Registry status
NA
Development phase
179
Enrollment target
11
Study locations

NCT01220011 is a NA study of Infant, Newborn, Diseases and Hematologic Disease that has completed, run by Assistance Publique - Hôpitaux de Paris. The registered enrollment target is 179 participants, below the 740-participant average among 8 other Infant, Newborn, Diseases trials with a reported enrollment target (76% lower). The trial reports 11 study locations across 10 states.

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The verdict

NCT01220011, a NA study of Infant, Newborn, Diseases and Hematologic Disease, has completed, sponsored by Assistance Publique - Hôpitaux de Paris.

COMPLETED
Registry status
NA
Development phase
179 participants
Enrollment target
11
Study locations

Study Summary

The objective of this trial is to compare both strategies (Expectative Vs Fetoscopic laser surgery) for patients with stage 1 TTTS and favorable obstetrical parameters in an international randomized controlled trial. This trial will answer an important question and will help in the management and tailoring of surgical indications in stage 1 TTTS.

Interventions

  • PROCEDURE Fetoscopic laser surgery

Study Locations (11)

Ohio

  • Fetal Care Center of Cincinnati, Cincinnati Children's Hospital Medical Center - Cincinnati
  • The Ohio State University / OSU Fetal Therapy Program - Columbus

Colorado

  • Children's Hospital Colorado and Colorado Fetal Care Center - Aurora

Maryland

  • University of MD /Department of Obstetrics, Gynecology & Reproductive Sciences - Baltimore

Pennsylvania

  • Fetal Diagnosis and Treatment, The Children's Hospital of Philadelphia - Philadelphia

Rhode Island

  • Fetal Treatment Program of New England, Hasbro Children's Hospital, The Warren Alpert Medical School of Brown University. - Providence

Texas

  • The Texas Fetal Center, Children's Memorial Hermann Hospital, University of Texas Medical School - Houston

Washington

  • Fetal Therapy Program, Evergrenn Hospital Medical Center - Kirkland

Ontario

  • Mount Sinai Hospital, University of Toronto - Toronto

Trial Details

FieldValue
Enrollment Target 179 participants
Start Date 2011-04-19
Est. Completion 2019-03-31
Phase NA

What the Registry Record Tells You About NCT01220011

The ClinicalTrials.gov registry entry for NCT01220011 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 179 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 740-participant average among 8 other Infant, Newborn, Diseases trials with a reported enrollment target (76% lower). The listed sponsor is Assistance Publique - Hôpitaux de Paris, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Infant, Newborn, Diseases appearing as the primary indexed condition, and to 1 intervention - of which Fetoscopic laser surgery is the first listed.

NCT01220011 reports 11 study locations spanning 10 distinct geographic areas - top geographies include Ohio, Colorado, Maryland.

Frequently Asked Questions

What is clinical trial NCT01220011 about?

NCT01220011 is a clinical study titled "Randomized Controlled Trial Comparing a Conservative Management and Laser Surgery". The objective of this trial is to compare both strategies (Expectative Vs Fetoscopic laser surgery) for patients with stage 1 TTTS and favorable obstetrical parameters in an international randomized controlled trial. This trial will answer an important question and will help in the management and ta...

What is the current status of trial NCT01220011?

This trial is currently completed. It is a NA study. The enrollment target is 179 participants. The study started on 2011-04-19. Estimated completion is 2019-03-31.

What conditions does trial NCT01220011 study?

This clinical trial studies the following conditions: Infant, Newborn, Diseases, Hematologic Disease, Blood and Blood Disorders, Anemia, Neonatal.

What interventions are being tested in trial NCT01220011?

The interventions under investigation include: Fetoscopic laser surgery (PROCEDURE).

Who is sponsoring clinical trial NCT01220011?

This trial is sponsored by Assistance Publique - Hôpitaux de Paris, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01220011 being conducted?

This trial has 11 study locations across Colorado, Maryland, Ohio, Pennsylvania, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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