← Back to Search

Bipolar Sealer

Bipolar Sealer for Blood Loss in Hip Surgery

N/A
Waitlist Available
Led By Mohammad U Burney, MD
Research Sponsored by North Texas Medical Research Institute, PLLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intra-operative
Awards & highlights

Study Summary

This trial shows that using Werewolf Fastseal 6.0 Bipolar Sealer in hip surgery can help improve patient outcomes.

Who is the study for?
This trial is for adults aged 21-79 needing a hip replacement due to joint disease, who can follow the study plan and aren't bedridden. They must not have infections, bleeding disorders, severe heart or kidney issues, uncontrolled diabetes, or be on certain blood thinners. Pregnant women and those with recent surgeries or drug/alcohol abuse are excluded.Check my eligibility
What is being tested?
The study tests if the Werewolf Fastseal 6.0 Bipolar Sealer helps reduce blood loss during anterior total hip arthroplasty (hip replacement surgery) which could lead to better patient outcomes.See study design
What are the potential side effects?
While specific side effects of the Werewolf Fastseal device aren't listed here, similar devices may cause thermal damage to tissues or burns at the surgical site.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~taken at 48-72 hours post op
This trial's timeline: 3 weeks for screening, Varies for treatment, and taken at 48-72 hours post op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
intra-operative total blood loss
post-operative hemoglobin
Secondary outcome measures
Harris Hip Score analysis 6 weeks post operative visits
Mean operative time ("skin to skin")
Post-operative need for transfusion
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intervention Group Receiving FastsealExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

North Texas Medical Research Institute, PLLCLead Sponsor
Smith & Nephew, Inc.Industry Sponsor
165 Previous Clinical Trials
22,406 Total Patients Enrolled
32 Trials studying Osteoarthritis
4,638 Patients Enrolled for Osteoarthritis
Mohammad U Burney, MDPrincipal InvestigatorNTMRI, OSD

Media Library

Werewolf Fastseal 6.0 (Bipolar Sealer) Clinical Trial Eligibility Overview. Trial Name: NCT05356637 — N/A
Osteoarthritis Research Study Groups: Intervention Group Receiving Fastseal
Osteoarthritis Clinical Trial 2023: Werewolf Fastseal 6.0 Highlights & Side Effects. Trial Name: NCT05356637 — N/A
Werewolf Fastseal 6.0 (Bipolar Sealer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05356637 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research initiative still open to participants?

"Clinicaltrials.gov confirms that this medical study, first posted on April 29th 2022, is still looking for people to join the trial. The information was most recently revised in April 19th 2023."

Answered by AI

How many people has this clinical trial enrolled?

"Affirmative. The information provided on clinicaltrials.gov attests that this trial is actively recruiting participants; it was first posted in April 29th 2022 and last modified on April 19th 2023. 75 volunteers are needed to be recruited from two distinct medical facilities."

Answered by AI

What are the anticipated outcomes of this clinical experimentation?

"Smith & Nephew, Inc., the study's sponsor, has detailed that post-operative hemoglobin will be monitored over a given time period and serve as its primary outcome. This analysis also includes secondary outcomes such as transfusion need measured in units given, Venous Thromboembolism incidence assessed across 6 weeks, and operative duration registered in hh:mm:ss format."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Bipolar Sealer for Reduction of Blood Loss in Anterior Total Hip Arthroplasties
Mohammad Umar Burney, MD 2022. "Bipolar Sealer for Reduction of Blood Loss in Anterior Total Hip Arthroplasties". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05356637.
~26 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top