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

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ClinicalTrials.gov Identifier: NCT02883673
Recruitment Status : Recruiting
First Posted : August 30, 2016
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Alydia Health

Tracking Information
First Submitted Date  ICMJE August 25, 2016
First Posted Date  ICMJE August 30, 2016
Last Update Posted Date November 1, 2019
Actual Study Start Date  ICMJE September 17, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT02883673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage
Official Title  ICMJE Prospective, Single Arm Pivotal Clinical Trial Designed to Assess the Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postpartum Hemorrhage
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Intervention
Jada System for Postpartum Hemorrhage will be administered to subjects who are diagnosed with postpartum hemorrhage.
Intervention: Device: Jada System
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 18, 2017)
107
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kathryn D Wine, MPH 415-990-4104 kathryn@alydiahealth.com
Contact: Lisa Tehrani, MA 415-606-1601 lisa@alydiahealth.com
Listed Location Countries  ICMJE United States
Removed Location Countries Uganda
 
Administrative Information
NCT Number  ICMJE NCT02883673
Other Study ID Numbers  ICMJE CIP-01 v2.6
PPH-02 ( Other Identifier: Alydia Health )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alydia Health
Study Sponsor  ICMJE Alydia Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mary D'Alton, MD Columbia University
PRS Account Alydia Health
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP