Stapler Post-market Observational Study

Observational Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922205
• Other study ID #: ST-01
• Status: Completed
• Start date: April 6, 2017
• Est. completion date: September 16, 2020

Study information

• Verified date: November 2020
• Source: Duomed
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 16, 2020
• Est. primary completion date: September 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Observational

Intervention

Device:
• Endoscopic Linear Cutter Stapler and reloads
Endoscopic Linear Cutter Stapler and reloads

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Duomed

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events related to the index-procedure.	Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.	1 month follow-up
Primary	Number of patients with adverse events related to the index-procedure.	Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.	6 months follow-up
Secondary	Number of adverse device effects.	Determination of staple line disruption.	1, 6, 12 and 24 month follow-up
Secondary	Number of patients with bariatric surgery related re-interventions.		1, 6, 12 and 24 month follow-up
Secondary	Percentage of excess weight loss.	pre-operative weight (kg) minus postoperative weight (kg) divided by the ideal body weight (kg).	1, 6, 12 and month follow-up
Secondary	Questionnaire on food tolerance.		1, 6, 12 and 24 month follow-up