ObesityNCT02358785
Evaluation of a Powered Stapler System on Surgical Interventions Required During Laparoscopic Sleeve Gastrectomy
An observational study of Obesity, run by Ethicon Endo-Surgery at 4 sites in United States.
Trial summary
This study will provide clinical data in an observational setting. Individuals undergoing LSG, and who meet study entry criteria, may be enrolled. LSG procedures will be performed according to institutional standard-of-care (SOC) using the study stapler. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- ECHELON FLEX™ Powered Plus Stapler
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jan 2015to 1 Nov 2015
- 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: Individuals scheduled for laparoscopic sleeve gastrectomy
Who may be able to join
- Scheduled for laparoscopic sleeve gastrectomy;
- Subject meets NIH weight loss surgical criteria;
- BMI ≤ 60 kg/m2;
- Willing to give consent and comply with study-related evaluations; and
- At least 18 years of age
Who cannot join
- Previous bariatric procedures, including gastric banding;
- Prior gastric surgery;
- Scheduled concurrent surgical procedure (hiatal hernia repair, cholecystectomy allowed);
- Pregnancy;
- Known or suspected uncontrolled bleeding disorders;
- History of chronic steroid use;
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- Patients who have undergone significant upper GI surgery leading to adhesion; formation, as determined by the Principal Investigator;
- Physical or psychological condition which would impair study participation;
- The patient is judged unsuitable for study participation by the Investigator for any other reason; or
- Unable or unwilling to attend follow-up visits and examinations.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Carolinas Weight Management
Charlotte, North Carolina, 28204
Greenville Health System
Greenville, South Carolina, 29605
Surgical Specialists of Louisiana
Metairie, Louisiana, 70001
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
This study will provide clinical data in an observational setting. Individuals undergoing LSG, and who meet study entry criteria, may be enrolled. LSG procedures will be performed according to institutional standard-of-care (SOC) using the study stapler. All study subjects will be followed for approximately 4 weeks for safety and outcomes.
- Conditions
- Obesity
- Being tested
- ECHELON FLEX™ Powered Plus Stapler
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECHELON FLEX™ Powered Plus StaplerDevice
ECHELON FLEX™ Powered Plus Stapler using ENDOPATH ECHELON™ Reloads with Gripping Surface Technology (GST). The combination of stapler plus reload is referred to as the ECHELON FLEX™ GST System.
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical interventions (type, quantity, frequency, rationale) required during LSG
Measured: Intraoperative
Secondary outcomes (3)
Procedure duration
Measured: Up to one day
Length of stay
Measured: Up to 4 weeks
Estimated blood loss
Measured: up to one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study start1 Jan 2015
- Primary completion1 Oct 2015
- Study completion1 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adolfo Fernandez, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358785
- Sponsor's protocol ID
- ESC-14-005
- Status last verified
- Aug 2017
- First submitted
- 30 Jan 2015
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: via publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Powered Stapler System on Surgical Interventions Required During Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT02358785
- Acronym / sponsor ID
- ESC-14-005
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Oct 2015 (actual)
- Study completion
- 1 Nov 2015 (actual)
- First posted
- 9 Feb 2015 (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.
This study will provide clinical data in an observational setting. Individuals undergoing LSG, and who meet study entry criteria, may be enrolled. LSG procedures will be performed according to institutional standard-of-care (SOC) using the study stapler. All study subjects will be followed for approximately 4 weeks for safety and outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals scheduled for laparoscopic sleeve gastrectomy
Key inclusion criteria (5 listed)
- Scheduled for laparoscopic sleeve gastrectomy;
- Subject meets NIH weight loss surgical criteria;
- BMI ≤ 60 kg/m2;
- Willing to give consent and comply with study-related evaluations; and
- At least 18 years of age
Key exclusion criteria (10 listed)
- Previous bariatric procedures, including gastric banding;
- Prior gastric surgery;
- Scheduled concurrent surgical procedure (hiatal hernia repair, cholecystectomy allowed);
- Pregnancy;
- Known or suspected uncontrolled bleeding disorders;
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 |
|---|---|---|
| ECHELON FLEX™ Powered Plus StaplerECHELON FLEX™ Powered Plus Stapler using ENDOPATH ECHELON™ Reloads with Gripping Surface Technology (GST). The combination of stapler plus reload is referred to as the ECHELON FLEX™ GST System. | Device | – |
Primary outcome
Surgical interventions (type, quantity, frequency, rationale) required during LSG
Time frame: Intraoperative
3 secondary outcomes
Procedure duration
Time frame: Up to one day
Length of stay
Time frame: Up to 4 weeks
Estimated blood loss
Time frame: up to one day
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 11 Aug 2017.
- Individual participant dataSharing planned: Yes. via publication
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Obesity
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.
Adolfo Fernandez, MD principal investigator
Wake Forest University Health Sciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Ethicon Endo-Surgery at 4 sites 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 5 inclusion and 10 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 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Surgical interventions (type, quantity, frequency, rationale) required during LSG (time frame: Intraoperative). 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 11 Aug 2017.