Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Winston-Salem, North Carolina 27157


Purpose:

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.


Criteria:

Inclusion Criteria: - Scheduled for laparoscopic sleeve gastrectomy; - Subject meets NIH weight loss surgical criteria; - BMI ≤ 60 kg/m2; - Willing to give consent and comply with study-related evaluations; and - At least 18 years of age Exclusion Criteria: - Previous bariatric procedures, including gastric banding; - Prior gastric surgery; - Scheduled concurrent surgical procedure (hiatal hernia repair, cholecystectomy allowed); - Pregnancy; - Known or suspected uncontrolled bleeding disorders; - History of chronic steroid use; - Patients who have undergone significant upper GI surgery leading to adhesion; formation, as determined by the Principal Investigator; - Physical or psychological condition which would impair study participation; - The patient is judged unsuitable for study participation by the Investigator for any other reason; or - Unable or unwilling to attend follow-up visits and examinations.


NCT ID:

NCT02358785


Primary Contact:

Principal Investigator
Adolfo Fernandez, MD
Wake Forest University Health Sciences


Backup Contact:

N/A


Location Contact:

Winston-Salem, North Carolina 27157
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.