ObservationalNCT02922205
Stapler Post-market Observational Study
An observational study of Observational, run by Duomed at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Observational
- What is being tested?
- Endoscopic Linear Cutter Stapler and reloads
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Apr 2017to 16 Sep 2020
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese patients eligible for laparoscopic Roux-en-Y gastric bypass surgery.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler in Laparoscopic Gastric Bypass Surgery.
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
- Being tested
- Endoscopic Linear Cutter Stapler and reloads
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Linear Cutter Stapler and reloadsDevice
Endoscopic Linear Cutter Stapler and reloads
| Study group | Role | What they receive |
|---|---|---|
| RYGB surgery | Obese patients eligible for laparoscopic Roux-en-Y gastric bypass (RYGB) surgery. Receives: Device: Endoscopic Linear Cutter Stapler and reloads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events related to the index-procedure.
Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.
Measured: 1 month follow-up
Number of patients with adverse events related to the index-procedure.
Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.
Measured: 6 months follow-up
Secondary outcomes (4)
Number of adverse device effects.
Determination of staple line disruption.
Measured: 1, 6, 12 and 24 month follow-up
Number of patients with bariatric surgery related re-interventions.
Measured: 1, 6, 12 and 24 month follow-up
Percentage of excess weight loss.
pre-operative weight (kg) minus postoperative weight (kg) divided by the ideal body weight (kg).
Measured: 1, 6, 12 and month follow-up
Questionnaire on food tolerance.
Measured: 1, 6, 12 and 24 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start6 Apr 2017
- Primary completion16 Sep 2020
- Study completion16 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObservationalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Duomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans Verhelst, Dr., Principal investigator, ZOL, Genk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922205
- Sponsor's protocol ID
- ST-01
- Status last verified
- Nov 2020
- First submitted
- 28 Sep 2016
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler in Laparoscopic Gastric Bypass Surgery.
- ClinicalTrials.gov ID
- NCT02922205
- Acronym / sponsor ID
- ST-01
- Conditions
- Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- DuomedIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 16 Sep 2020 (actual)
- Study completion
- 16 Sep 2020 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RYGB surgery | – | Device: Endoscopic Linear Cutter Stapler and reloadsObese patients eligible for laparoscopic Roux-en-Y gastric bypass (RYGB) surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients eligible for laparoscopic Roux-en-Y gastric bypass surgery.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Linear Cutter Stapler and reloadsEndoscopic Linear Cutter Stapler and reloads | Device | RYGB surgery |
Primary outcome
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.
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.
4 secondary outcomes
Number of adverse device effects.
Time frame: 1, 6, 12 and 24 month follow-up
Number of patients with bariatric surgery related re-interventions.
Time frame: 1, 6, 12 and 24 month follow-up
Percentage of excess weight loss.
Time frame: 1, 6, 12 and month follow-up
Questionnaire on food tolerance.
Time frame: 1, 6, 12 and 24 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Verhelst, Dr. principal investigator
ZOL, Genk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Observational, run by Duomed at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events related to the index-procedure. (time frame: 1 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.