The objective of this feasibility trial is to evaluate the Ethicon Endo-Surgery Endoscopic Suturing System (ESS) for tissue apposition and reduction of the size of a dilated GJ anastomosis in subjects who are regaining weight after successful weight loss following gastric bypass. Post-procedure weight will be followed to assess whether weight loss is resumed. The ESS is an FDA-cleared (510(k)) sterile, single-use, disposable suturing system indicated for endoscopic placement of suture(s) and approximation of soft tissues. It is designed to facilitate endoscopic gastrointestinal procedures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Tissue apposition and plication of a dilated GJ anastomosis with the Endoscopic Suturing System
Tissue plication of dilated GJ stoma
Tissue plication for GJ stoma reduction
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Knotting Elements Placed
completion of plication (1-3 knotting elements placed per procedure)
Time frame: intra-operative
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.