Recruiting
Phase 1

ClotFoam

Sponsor:

Biomedica Management Corporation

Code:

NCT02264730

Conditions

Bleeding

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

ClotFoam

Study Details

Brief summary:

Phase 1 Single-Arm Study Evaluating ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery in Which Liver Bleeding is Encountered.

Conditions

Bleeding

Study ID

NCT02264730

Start date

Jul, 2014

Status verified date

Oct, 2014

Completion date

Jan, 2015

Anticipated

Primary completion date

Jan, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Subject is expected to survive 6 months from the date of screening, If female and of child-bearing potential, subject has a negative serum pregnancy test prior to surgery and agrees to not breast feed her child (if applicable) for duration of study treatment and completion of study follow-up visits, If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits

Exclusion Criteria:

  • pregnant females

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Clot Foam

Application of Clotfoam

Interventions

ClotFoam

Patient has not received blood products between screenings

Primary outcome measure

  • control mild-to-moderate bleeding during surgery in which liver bleeding in encountered [ Time Frame: 12 weeks ]

Central Contacts and Locations

Locations

Washington University School of Medicine Barnes Jewish Hospital Clinical Laboratory

Recruiting

St. Louis, Missouri, United States, 63130

Contacts

Grant Bochicchio, MD, MPH FACS

314-747-3000

Jessica Smith, MD

(314) 747-3000

More Information

Sponsor

Biomedica Management Corporation

Last update posted

Oct 15, 2014

Last verified

Oct, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Biomedica Management Corporation on 2014-10-15.