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Completed

NCT Number: NCT02922205

Stapler Post-market Observational Study

The purpose of this observational study is to evaluate the safety and performance of the Endoscopic Linear Cutter Stapler and reloads from Fengh Medical used in laparoscopic Roux-en-Y gastric bypass surgery to create anastomoses. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.

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Key information

Conditions

Observational

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age at study entry is at least 18 years.
  • Patient must sign and date the informed consent form prior to the index-procedure.
  • Patient has a BMI ≥ 35 kg/m with one or more related co-morbidity.
  • Patient has a BMI ≥ 40 kg/m.

Exclusion criteria

  • Patient is pregnant.
  • History of bariatric surgery.
  • Patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits.

Treatment and study plan

Endoscopic Linear Cutter Stapler and reloads

Device

Endoscopic Linear Cutter Stapler and reloads

Primary outcomes

  1. Number of patients with adverse events related to the index-procedure.

    Time frame: 1 month follow-up

    Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.

  2. Number of patients with adverse events related to the index-procedure.

    Time frame: 6 months follow-up

    Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.

Secondary outcomes

  1. Number of adverse device effects.

    Time frame: 1, 6, 12 and 24 month follow-up

    Determination of staple line disruption.

  2. Number of patients with bariatric surgery related re-interventions.

    Time frame: 1, 6, 12 and 24 month follow-up

  3. Percentage of excess weight loss.

    Time frame: 1, 6, 12 and month follow-up

    pre-operative weight (kg) minus postoperative weight (kg) divided by the ideal body weight (kg).

  4. Questionnaire on food tolerance.

    Time frame: 1, 6, 12 and 24 month follow-up

Sponsors and collaborators

Lead sponsor

Duomed

Industry

Registry information

Official study title

Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler in Laparoscopic Gastric Bypass Surgery.

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 4, 2016
Registry last updated
Nov 6, 2020

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.

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