Sleep ApneaNCT01026103

Tri Staple Technology Stapler Used in Gastric Bypass

A study testing Tri Staple Technology stapler in people with Sleep Apnea and Hypertension, run by Medtronic - MITG at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objectives of this clinical trial are to assess in a pilot setting the overall performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™ Technology when used in a gastric bypass procedure. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Sleep Apnea, Hypertension, Hyperlipidemia
What is being tested?: Tri Staple Technology stapler
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: Jan 2010to Mar 2011
Phase: Interventional
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

The patient must be 18-65 years of age.
The patient has a BMI of 40-60 kg/m2, or 35-40 kg/m2 with one or more of following comorbidities: sleep apnea, hypertension, hyperlipidemia, coronary artery disease, gastro esophageal reflux disease, osteoarthritis, and diabetes and eligible for gastric bypass.
The patient must be willing and able to participate in the study procedures and able to understand and sign the informed consent.

Who cannot join

The procedure is needed as revision bariatric surgery or the patient has had prior gastric surgery (nissen fundoplication, hiatal hernia, etc)
The patient is pregnant.
The patient has an active or history of, infection at the operative site.
The patient is unable or unwilling to comply with the study requirements, follow-up schedule, or to give valid informed consent.
Patient has an abdominal ventral hernia requiring mesh repair
The patient has a history of clinically significant liver disease

Show all 9Show fewer

The patient has a history of drug or alcohol abuse within 2 years of enrollment
The patient has a history of venous thrombosis or pulmonary embolism
The patient has a history of coagulopathy

Trial locations and contacts

1 site in 1 country.

United States1 site

Clarian Bariatric Center/Indiana University
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: A Prospective, Single-center Investigation of the Safety and Performance of the Endo GIA™ Stapler With Endo GIA™ Sulu With Tri-Staple™ Technology in a Gastric Bypass Procedure

Conditions: Sleep Apnea, Hypertension, Hyperlipidemia, Coronary Artery Disease, Gastroesophageal Reflux Disease, Osteoarthritis
Being tested: Tri Staple Technology stapler
Keywords: gastric bypass, Gastric bypass surgery
Medical subject headings: Sleep Apnea Syndromes, Hypertension, Hyperlipidemias, Coronary Artery Disease, Gastroesophageal Reflux, Osteoarthritis, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tri Staple Technology staplerDevice
This is a single arm study.

Study groups in NCT01026103
Study group	Role	What they receive
Tri Staple	Experimental	This is a single arm study. Receives: Device: Tri Staple Technology stapler

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Patients With an Uneventful Creation of a Functional Staple Line
Measured: Day 0

Secondary outcomes (3)

Incidence of Intra-operative Bleeding Requiring Intervention
Measured: Day 0 and 1 month
Length of Hospital Stay
Measured: Date of discharge which averages 3 days
Incidence of Serosal Tearing
Measured: 30 days post op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Mar 2011

First posted4 Dec 2009 (estimated)
Study startJan 2010
Primary completionMar 2011
Study completionMar 2011

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 Sleep ApneaStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01026103
Sponsor's protocol ID: AS09004
Status last verified: Jan 2014
First submitted: 3 Dec 2009
Last updated: 14 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
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Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
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All Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Single-center Investigation of the Safety and Performance of the Endo GIA™ Stapler With Endo GIA™ Sulu With Tri-Staple™ Technology in a Gastric Bypass Procedure
ClinicalTrials.gov ID: NCT01026103
Acronym / sponsor ID: AS09004
Conditions: Sleep Apnea, Hypertension, Hyperlipidemia, Coronary Artery Disease, Gastroesophageal Reflux Disease, Osteoarthritis
Keywords: gastric bypass, Gastric bypass surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Medtronic - MITGIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 4 Dec 2009 (estimated)
Results: Posted 14 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tri Staple	Experimental	Device: Tri Staple Technology staplerThis is a single arm study.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

The patient must be 18-65 years of age.
The patient has a BMI of 40-60 kg/m2, or 35-40 kg/m2 with one or more of following comorbidities: sleep apnea, hypertension, hyperlipidemia, coronary artery disease, gastro esophageal reflux disease, osteoarthritis, and diabetes and eligible for gastric bypass.
The patient must be willing and able to participate in the study procedures and able to understand and sign the informed consent.

Key exclusion criteria (9 listed)

The procedure is needed as revision bariatric surgery or the patient has had prior gastric surgery (nissen fundoplication, hiatal hernia, etc)
The patient is pregnant.
The patient has an active or history of, infection at the operative site.
The patient is unable or unwilling to comply with the study requirements, follow-up schedule, or to give valid informed consent.
Patient has an abdominal ventral hernia requiring mesh repair

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
Tri Staple Technology staplerThis is a single arm study.	Device	Tri Staple

Primary outcome

Proportion of Patients With an Uneventful Creation of a Functional Staple Line
Time frame: Day 0

3 secondary outcomes

Incidence of Intra-operative Bleeding Requiring Intervention
Time frame: Day 0 and 1 month
Length of Hospital Stay
Time frame: Date of discharge which averages 3 days
Incidence of Serosal Tearing
Time frame: 30 days post op

Results and safety

Results posted to the registry on 14 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tri Staple	30	28

Primary outcome: Proportion of Patients With an Uneventful Creation of a Functional Staple Line

Time frame: Day 0. Number. Unit: participants

Measure	Tri Staple n = 28
Value	28 (88 to 100)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days post surgery. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tri Staple	2 of 28 (7.1%)	24 of 28 (85.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Sleep Apnea

Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
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Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
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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.

Samer G Mattar, MD principal investigator

Indiana University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Tri Staple Technology stapler in people with Sleep Apnea and Hypertension, run by Medtronic - MITG 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 3 inclusion and 9 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 14 Mar 2014. 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 14 Mar 2014). 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?

Proportion of Patients With an Uneventful Creation of a Functional Staple Line (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01026103.

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 14 Mar 2014.