Skip to main content
OpenTrials
Completed

NCT Number: NCT02358785

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Surgical Specialists of Louisiana, Metairie, Louisiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ECHELON FLEX™ Powered Plus Stapler

Device

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.

Primary outcomes

  1. Surgical interventions (type, quantity, frequency, rationale) required during LSG

    Time frame: Intraoperative

Secondary outcomes

  1. Procedure duration

    Time frame: Up to one day

  2. Length of stay

    Time frame: Up to 4 weeks

  3. Estimated blood loss

    Time frame: up to one day

Sponsors and collaborators

Lead sponsor

Ethicon Endo-Surgery

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 9, 2015
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.