Clinical Trial: Safety and Effectiveness of the InPress Device in Treating Primary Postpartum Hemorrhage

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prospective, Single Arm Pivotal Clinical Trial Designed to Assess the Safety and Performance of the InPress Device in Treating Primary Postpartum Hemorrhage

Brief Summary: The purpose of this study is to assess the safety and effectiveness of the InPress Device in treating primary postpartum hemorrhage.

Detailed Summary:
Sponsor: InPress Technologies

Current Primary Outcome:

• Efficacy: Cessation of uterine hemorrhaging [ Time Frame: 24 hrs ]
  Cessation of uterine hemorrhaging, defined as average blood loss below 21 milliliters per hour (approximately 2/3 ounce/hour; 500ml/24 hours) into the vacuum canister within the first 24 hour period from start of the vacuum with placement of the InPress Device for vaginal deliveries, and average blood loss below 42 milliliters per hour, 1000 ml/ 24 hours into the vacuum canister within the first 24 hour period from start of the vacuum with placement of the InPress Device for Cesarean Section deliveries.
• Safety: Incidence and severity of device-related Adverse Events [ Time Frame: 6 weeks ]
  Incidence and severity of device-related Adverse Events (i.e., damage to the uterus, cervix, or vagina, infections, pyrexia, foreign body reactions) will be documented during the course of the study.

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: InPress Technologies

Dates:
Date Received: August 25, 2016
Date Started: November 2016
Date Completion: September 2018
Last Updated: December 3, 2016
Last Verified: December 2016