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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: Completed NA study of Infant, Newborn, Diseases and Hematologic Disease, sponsored by Assistance Publique - Hôpitaux de Paris.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 179 participants |
| Start Date | 2011-04-19 |
| Est. Completion | 2019-03-31 |
| Phase | NA |
What the finished NCT01220011 record still lists
NCT01220011 is an interventional study that assigns participants to a tested intervention. The registered 179 participants enrollment target is mid-sized for trials with a published cap, below the 740-participant average among 8 other Infant, Newborn, Diseases trials with a reported enrollment target (76% lower).
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 lists 11 locations in 10 states (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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Where NCT01220011's enrollment target sits among peer trials
179 5th of 8 higher than 4 of 8 other Infant, Newborn, Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infant, Newborn, Diseases 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.
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