Gastric ResectionNCT04086433
Gastric Tissue Stapler Comparison Study
An observational study of Gastric Resection, run by Standard Bariatrics at 1 site in United States.
Trial summary
This study is conducted to compare performance characteristics of staple lines resecting the stomach in excised human gastric tissue with existing Echelon Flex Powered Plus GST System (Ethicon, size: 60mm, "Echelon") stapler and the Titan SGS (Standard Bariatrics, "Titan"). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Resection
- What is being tested?
- gastric tissue resection
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 30 Oct 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- Adult, Older adult
Study population: Subjects undergoing Laparoscopic Sleeve Gastrectomy
Who may be able to join
- 1. Laparoscopic sleeve gastrectomy patients at study site, ages 18 to 80
Who cannot join
- Prior gastric surgery (lap band, Nissen fundoplication, G tube, greater curve plication, etc.)
- Gastric lesion recognized during surgery (entire specimen would be sent to pathology)
- Stomach damaged during extraction
Trial locations and contacts
1 site in 1 country.
About this study
This study is conducted to compare performance characteristics of staple lines resecting the stomach in excised human gastric tissue with existing Echelon Flex Powered Plus GST System (Ethicon, size: 60mm, "Echelon") stapler and the Titan SGS (Standard Bariatrics, "Titan").
The Study is a single center clinical trial, randomized (1:1, Arm A - Ethicon Echelon 60 application, Arm B - Standard Bariatrics Titan SGS application) which utilizes the excised stomach tissue from up to 75 adults undergoing laparoscopic sleeve gastrectomy (LSG). This study will be conducted in the USA.
- Conditions
- Gastric Resection
- Being tested
- gastric tissue resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric tissue resectionDevice
human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Echelon Stapler | Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, "Echelon") and evaluated for burst pressure and staple malformation Receives: Device: gastric tissue resection | |
| Arm B - Titan Stapler | Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, "Titan") and evaluated for burst pressure and staple malformation Receives: Device: gastric tissue resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Evaluation
Burst pressure will be assessed in the specimen with one staple line (i.e. the test staple line) with a pressure volume curve recorded.
Measured: immediately post operative
Staple Malformation
Staple line specimen will be sent to an independent laboratory for imaging. Percentage of malformed staples in test staple line will be recorded by an independent assessor.
Measured: through study completion, anticipate within 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start15 Jul 2019
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric ResectionStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Standard Bariatrics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aaron B Hoffman, MD, FACS, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086433
- Sponsor's protocol ID
- CP-2018-01
- Status last verified
- Jun 2020
- First submitted
- 29 Jul 2019
- Last updated
- 25 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Tissue Stapler Comparison Study
- ClinicalTrials.gov ID
- NCT04086433
- Acronym / sponsor ID
- CP-2018-01
- Conditions
- Gastric Resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Standard BariatricsIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Posted 5 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is conducted to compare performance characteristics of staple lines resecting the stomach in excised human gastric tissue with existing Echelon Flex Powered Plus GST System (Ethicon, size: 60mm, "Echelon") stapler and the Titan SGS (Standard Bariatrics, "Titan").
The Study is a single center clinical trial, randomized (1:1, Arm A - Ethicon Echelon 60 application, Arm B - Standard Bariatrics Titan SGS application) which utilizes the excised stomach tissue from up to 75 adults undergoing laparoscopic sleeve gastrectomy (LSG). This study will be conducted in the USA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A - Echelon Stapler | – | Device: gastric tissue resectionExcised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, "Echelon") and evaluated for burst pressure and staple malformation |
| Arm B - Titan Stapler | – | Device: gastric tissue resectionExcised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, "Titan") and evaluated for burst pressure and staple malformation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing Laparoscopic Sleeve Gastrectomy
Key inclusion criteria (1 listed)
- 1. Laparoscopic sleeve gastrectomy patients at study site, ages 18 to 80
Key exclusion criteria (3 listed)
- Prior gastric surgery (lap band, Nissen fundoplication, G tube, greater curve plication, etc.)
- Gastric lesion recognized during surgery (entire specimen would be sent to pathology)
- Stomach damaged during extraction
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 |
|---|---|---|
| gastric tissue resectionhuman stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment | Device | Arm A - Echelon Stapler, Arm B - Titan Stapler |
Primary outcome
Pressure Evaluation
Time frame: immediately post operative
Burst pressure will be assessed in the specimen with one staple line (i.e. the test staple line) with a pressure volume curve recorded.
Staple Malformation
Time frame: through study completion, anticipate within 2 months
Staple line specimen will be sent to an independent laboratory for imaging. Percentage of malformed staples in test staple line will be recorded by an independent assessor.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Aaron B Hoffman, MD, FACS principal investigator
University at Buffalo
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 Gastric Resection, run by Standard Bariatrics at 1 site in United States.
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 1 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 25 Jun 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pressure Evaluation (time frame: immediately post operative). 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 25 Jun 2020.