A newly announced clinical study is set to evaluate the safety and performance of EmboBio, an innovative medical device for treating abdominopelvic bleeding during surgery. The trial, sponsored by EmboBio Medical, will focus on its intra-arterial application. Healthcare professionals involved in emergency care, vascular surgery, and interventional radiology may find this study particularly relevant. As of now, the study is marked as “Not yet recruiting,” pending participant enrollment.
What is the scope of this study?
The clinical trial will assess the use of EmboBio for the intra-arterial treatment of bleeding during abdominopelvic surgeries. While specific technical details about the device have not been disclosed, its intended purpose is rooted in embolization therapy. This method involves blocking blood flow to manage severe bleeding.
The study is specifically sponsored by EmboBio Medical, the device’s manufacturer. The inclusion of manufacturer sponsorship may support closer adherence to performance monitoring under medical device regulatory standards.
Given its status as “Not yet recruiting,” no timeline has been provided for participant selection or enrollment at this time.
Which conditions does EmboBio target?
EmboBio is designed for use during abdominopelvic surgical interventions where bleeding control is critical. Conditions such as trauma, post-surgical complications, or vascular abnormalities could be key treatment scenarios for this device.
EmboBio utilizes embolization, a widely accepted procedure for minimizing blood loss and stabilizing patients during medical emergencies. Such devices are instrumental in reducing operative risks and improving patient outcomes in complex surgeries.
How does this align with regulatory standards?
Under Annex XIV of the Medical Device Regulation (MDR), clinical investigations must demonstrate a device’s safety, performance, and intended purpose. This EmboBio trial complies with those principles by investigating its efficacy in real-world applications.
The study’s focus aligns with regulatory expectations for post-market surveillance and risk-benefit analysis. The results will likely contribute to its future positioning within interventional radiology and surgical care protocols.
For regulatory and quality teams, this study may offer detailed insights into the manufacturer’s approach to compliance monitoring and end-user safety.
FAQs
1. When will recruitment begin?
As of the announcement date, the study is marked “Not yet recruiting.” No specific timeline has been disclosed.
2. Who sponsors this clinical study?
The clinical trial is sponsored by EmboBio Medical, reflecting its interest in validating the device’s real-world efficacy.
3. What is embolization therapy?
Embolization involves occluding blood vessels to control bleeding. It is commonly used in emergency medicine or surgery.
4. Where can I find more details?
The official listing for this trial is available on ClinicalTrials.gov. See the link at the end of this article.
Key takeaways
EmboBio’s upcoming clinical trial aims to address critical safety and performance metrics for its use in controlling abdominopelvic bleeding. Regulatory teams may find the study useful for monitoring compliance trends, while clinical teams can look forward to potential advancements in intra-arterial embolization techniques.
Given its potential impact on surgical outcomes, this trial will be closely watched within the broader healthcare community. Participants and stakeholders should monitor progress for recruitment updates.
Disclaimer
This article is intended for informational purposes only. It does not constitute legal, regulatory, or clinical advice. Always refer to official sources for compliance matters.
Official announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07199348?term=medical+device