Stapler Post-market Observational Study

NCT02922205 | Completed

• 1 other identifier: ST-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Observational

Outcome Measures

Primary Outcomes (2)

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

  Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.

  1 month follow-up

• 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 Outcomes (4)

• Number of adverse device effects.

  1, 6, 12 and 24 month follow-up

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

  1, 6, 12 and 24 month follow-up

• Percentage of excess weight loss.

  1, 6, 12 and month follow-up

• Questionnaire on food tolerance.

  1, 6, 12 and 24 month follow-up

Study Arms (1)

RYGB surgery

Obese patients eligible for laparoscopic Roux-en-Y gastric bypass (RYGB) surgery.

Device: Endoscopic Linear Cutter Stapler and reloads

Interventions

Endoscopic Linear Cutter Stapler and reloads DEVICE

Endoscopic Linear Cutter Stapler and reloads

RYGB surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese patients eligible for laparoscopic Roux-en-Y gastric bypass surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duomed: lead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

Study Officials

• Hans Verhelst, Dr.

  ZOL, Genk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 4, 2016
• Study Start: April 6, 2017
• Primary Completion: September 16, 2020
• Study Completion: September 16, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)