Completed

NCT Number: NCT01719172

A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue

The objective of this study is to determine the safety of Veriset™ Hemostatic Patch when used during non-emergent, open, soft tissue surgery where a topical hemostatic agent would be used.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-emergent, Soft Tissue Procedures, Performed Via an Open Approach

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Innsbruck, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject or authorized representative has provided informed consent.
Subject is ≥ 18 years old.
Subject is scheduled for nonemergent surgery where a topical hemostatic agent would be used to control bleeding emanating from a tissue bed following organ dissection or removal or a bleeding tumor tissue bed following resection or dissection, via an open approach.
Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
Subject has an appropriate Target Bleeding Site (TBS) during the surgical procedure.
TBS bleeding assessment is Type 2 or 3 (refer to table in protocol).

Exclusion criteria

Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding.
Subject has an estimated life expectancy of less than 6 months.
Subject is scheduled for another planned surgery and the subsequent surgery would jeopardize the previous application of study treatment.
Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death.
Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with the study.
Subject has an active local infection at the TBS.
The investigator determines that participation in the study may jeopardize teh safety or welfare of the subject.

Treatment and study plan

Veriset™ Hemostatic Patch

Device

Topical Hemostat

Primary outcomes

Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment

Time frame: Intra-operative (Day 0)

Success will be defined as hemostasis obtained within 5 minutes. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.

Secondary outcomes

Proportion of Subjects Who Achieve Hemostasis Within 1 Minute

Time frame: Intra-operative (Day 0)

Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
Median Time to Achieve Hemostasis

Time frame: Intra-operative (Day 0)

Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Nov 1, 2012
Registry last updated: Feb 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.