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Evaluation of a Powered Stapler System on Surgical Interventions Required During Laparoscopic Sleeve Gastrectomy

NCT02358785 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2017-08-11

No results posted yet for this study

Summary

This study will provide clinical data in an observational setting. Individuals undergoing LSG, and who meet study entry criteria, may be enrolled. LSG procedures will be performed according to institutional standard-of-care (SOC) using the study stapler. All study subjects will be followed for approximately 4 weeks for safety and outcomes.

Conditions

Interventions

DEVICE

ECHELON FLEX™ Powered Plus Stapler

ECHELON FLEX™ Powered Plus Stapler using ENDOPATH ECHELON™ Reloads with Gripping Surface Technology (GST). The combination of stapler plus reload is referred to as the ECHELON FLEX™ GST System.

Sponsors & Collaborators

  • Ethicon Endo-Surgery

    lead INDUSTRY

Principal Investigators

  • Adolfo Fernandez, MD · Wake Forest University Health Sciences

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2015-10-01
Completion
2015-11-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02358785 on ClinicalTrials.gov