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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02358785

Enrollment

100

Registered

2015-02-09

Start date

2015-01-01

Completion date

2015-11-01

Last updated

2017-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief 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.

Interventions

DEVICEECHELON 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Surgical interventions (type, quantity, frequency, rationale) required during LSG	Intraoperative

Secondary

Measure	Time frame
Procedure duration	Up to one day
Length of stay	Up to 4 weeks
Estimated blood loss	up to one day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026