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Staple Line Reinforcement

Staple Line Reinforcement for Gastric Procedures

N/A
Waitlist Available
Led By Linda Martin, MD
Research Sponsored by Ethicon Endo-Surgery
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 from day 0 (day of surgery) through 70 days post-surgery
Awards & highlights

Study Summary

This trial will collect data on the safety and effectiveness of the ECHELON ENDOPATH stapler in routine gastric and thoracic surgery.

Eligible Conditions
  • Gastric Procedures
  • Lung Resection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 0 (day of surgery) through 70 days post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 0 (day of surgery) through 70 days post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures
Number of Participants Who Experienced Specific Device-related Adverse Events Through 70 Days
Secondary outcome measures
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback
Number of Study Devices Replaced During Surgery

Trial Design

1Treatment groups
Experimental Treatment
Group I: Gastric and thoracic staple line reinforcementExperimental Treatment1 Intervention
ECHELON ENDOPATH Staple Line Reinforcement is used during a gastric or thoracic procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Staple Line Reinforcement
2020
N/A
~240

Find a Location

Who is running the clinical trial?

Ethicon Endo-SurgeryLead Sponsor
83 Previous Clinical Trials
35,570 Total Patients Enrolled
Linda Martin, MDPrincipal InvestigatorUniversity of Virginia
Andrew Wheeler, MDPrincipal InvestigatorUniversity of Missouri-Columbia
2 Previous Clinical Trials
900 Total Patients Enrolled

Frequently Asked Questions

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

Are there multiple venues in this state engaged with the research?

"This research trial is currently operational in 8 different centres, with Long Island Jewish Medical Center located in New york City, Atrium Health based out of Charlotte and Indiana University Hospital situated in Indianapolis marking some of the most noteworthy."

Answered by AI

Does this experiment allow for further volunteers to join?

"According to the details found on clinicaltrials.gov, this particular study is not actively seeking enrolment from participants at present. This trial was initially posted in September 2020 and edited for the last time in November 2022; however, there are other trials that may still be recruiting patients."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
How old are they?
18 - 65
What site did they apply to?
University of Missouri
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement
2020. "Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04544865.
~53 spots leftby Apr 2025
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