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Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage (PEARLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02883673
Recruitment Status : Recruiting
First Posted : August 30, 2016
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Alydia Health

Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of the Jada System in the control and reduction of primary postpartum hemorrhage.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Device: Jada System Not Applicable

Detailed Description:
This IDE study is designed to evaluate the effectiveness and safety of the Jada System to treat primary PPH. The study is literature controlled.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 107 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Single Arm Pivotal Clinical Trial Designed to Assess the Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage
Actual Study Start Date : September 17, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Jada System for Postpartum Hemorrhage will be administered to subjects who are diagnosed with postpartum hemorrhage.
Device: Jada System
It is a teardrop-shaped, soft silicone ring that is placed into the uterus, where gentle suction is applied to cause the uterus to contract and shrink in size, compressing the blood vessels so the bleeding stops.




Primary Outcome Measures :
  1. Efficacy: Cessation of uterine hemorrhaging [ Time Frame: 24 hrs ]
    Control of postpartum hemorrhage, defined as the avoidance of non-surgical, second-line or surgical intervention to control uterine hemorrhage after the use of the Jada System per the Instructions for Use

  2. Safety: Incidence, severity and seriousness of device-related Adverse Events [ Time Frame: 6 weeks ]
    Incidence, severity and seriousness of device-related Adverse Events will be documented during the course of the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult Female, 18 years of age or older at time of consent.
  2. Able to understand and provide informed consent to participate in the study.
  3. Diagnosis of PPH with suspected atony within 24 hours after vaginal or c-section delivery.
  4. EBL, to be determined when investigator is ready to have Jada peel pack opened: a) vaginal delivery: 500 - 1500 ml EBL or b) c-section delivery: 1000 - 1500 ml EBL.
  5. Failed first-line intervention of uterotonics and uterine massage/bimanual compression to stop bleeding. Note: Uterotonic administration may continue concomitant with and post Jada use.

Exclusion Criteria:

  1. EBL > 1500 ml, to be determined when investigator is ready to have the Jada peel pack opened.
  2. Delivery at a gestational age < 34 weeks.
  3. For C-sections: Cervix < 3 cm dilated before Jada use.
  4. PPH that the investigator determines to require more aggressive treatment, including any of the following: a) hysterectomy, b) b-lynch suture, c) uterine artery embolization or ligation, d) hypogastric ligation.
  5. Known uterine anomaly.
  6. Ongoing intrauterine pregnancy.
  7. Placenta abnormality including any of the following: a) known placenta accreta, b) retained placenta with known risk factors for placenta accreta (e.g. history of prior uterine surgery, including prior c-section and placenta previa), c) retained placenta without easy manual removal.
  8. Known uterine rupture.
  9. Unresolved uterine inversion.
  10. Subject has undergone intrauterine balloon therapy or uterine packing for tamponade treatment of this PPH prior to use of the Jada.
  11. Current cervical cancer.
  12. Current purulent infection of the vagina, cervix, uterus.
  13. Diagnosis of coagulopathy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883673


Contacts
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Contact: Kathryn D Wine, MPH 415-990-4104 kathryn@alydiahealth.com
Contact: Julio C Juarez, MBA 619-840-7387 julio@alydiahealth.com

Locations
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United States, Alabama
University of Alabama Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Nancy Saxon       nbsaxon@uabmc.edu   
Principal Investigator: Akila Subramaniam, MD         
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Tricia Moriarty    202-877-0486    patricia.l.moriarty@medstar.net   
Principal Investigator: Sara N Iqbal, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Alyssa Petersmann    317-948-0751    apcumber@iupui.edu   
Principal Investigator: Methodius Tuuli, MD         
Principal Investigator: Sherrine Ibrahim, MD         
United States, New Jersey
Rutgers Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Shama Khan, MPH       khansp@rwjms.rutgers.edu   
Principal Investigator: Todd Rosen, MD         
United States, New York
New York Presbyterian Queens Recruiting
Flushing, New York, United States, 11355
Contact: Rosalyn Chan, MD, MPH    718-670-1707    roc9166@nyp.org   
Principal Investigator: Armin Razavi, MD         
Principal Investigator: Dan Skupski, MD         
Nyph/Cumc Recruiting
New York, New York, United States, 10032
Contact: Caroline Torres       ct2179@cumc.columbia.edu   
Principal Investigator: Dena Goffman, MD         
United States, Ohio
MetroHealth Case Western Recruiting
Cleveland, Ohio, United States, 44109
Contact: Jodi Bell    216-778-3867    jbell3@metrohealth.org   
Principal Investigator: Edward Chien, MD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Taryn Summerfield    614-293-2122    taryn.summerfield@osumc.edu   
Principal Investigator: Kara Rood, MD         
United States, Pennsylvania
UPMC - Magee Women's Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Melissa Bickus, BS, RN    412-641-4072    bickmt2@upmc.edu   
Principal Investigator: Hyagriv Simhan, MD         
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Ashley Salazar       assalaza@utmb.edu   
Principal Investigator: Shannon Clark, MD         
UT Health Science Center, McGovern School of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Sunbola Ashimi, PhD    713-500-6412    sunbola.s.ashimi@uth.tmc.edu   
Principal Investigator: Nana Ankumah, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Marie Gibson    801-213-2845    Marie.Gibson@hsc.utah.edu   
Principal Investigator: Marcela Smid, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Amanda Urban    434-409-3100    AJR5Y@hscmail.mcc.virginia.edu   
Principal Investigator: Donald Dudley, MD         
United States, Wisconsin
St. Mary's Hospital Withdrawn
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
Alydia Health
Investigators
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Principal Investigator: Mary D'Alton, MD Columbia University

Publications:
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Responsible Party: Alydia Health
ClinicalTrials.gov Identifier: NCT02883673     History of Changes
Other Study ID Numbers: CIP-01 v2.6
PPH-02 ( Other Identifier: Alydia Health )
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Alydia Health:
Postpartum Hemorrhage

Additional relevant MeSH terms:
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Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage