Trials / Completed
CompletedNCT02883673
Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage
Prospective, Single Arm Pivotal Clinical Trial Designed to Assess the Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 107 (actual)
- Sponsor
- Alydia Health · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-09-17
- Primary completion
- 2020-01-26
- Completion
- 2020-03-25
- First posted
- 2016-08-30
- Last updated
- 2022-08-22
- Results posted
- 2022-04-12
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02883673. Inclusion in this directory is not an endorsement.