Conscious SedationNCT02573818
Sedasys Post Approval Study Users Response to System Alarms
An observational study of Conscious Sedation, run by Ethicon Endo-Surgery at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the users' responses to the SEDASYS® System alarms during esophagogastroduodenoscopy (EGD) or colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Conscious Sedation
- What is being tested?
- SEDASYS System
- Type of treatment
- Medical device
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2015to 15 Jun 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and female subjects 18 years or older scheduled for colonoscopy or EGD
Who may be able to join
- American Society of Anesthesiologists (ASA) I and II
- male and female
- Scheduled for routine colonoscopy or EGD
- ≥18 years of age
- Able to read, speak, and understand English
Who cannot join
- Physical or psychological condition which would impair trial participation, at the discretion of the PI
- BMI ≥ 35
- Pregnancy or lactation
- Known or suspected hypersensitivity to propofol or fentanyl
- Use of a fentanyl patch
- Allergies to eggs, egg products soybeans or soy products
Show all 10Show fewer
- Diagnosis of sleep apnea
- Gastroparesis
- Full stomach at the time of procedure
- Participation in any other investigational device or drug study within 30 days of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label Post Approval Study of the SEDASYS System User Response to System Alarms
The purpose of this study is to evaluate the users' responses to the SEDASYS® System alarms during esophagogastroduodenoscopy (EGD) or colonoscopy.
- Conditions
- Conscious Sedation
- Being tested
- SEDASYS System
- Keywords
- sedation for EGD and colonoscopy procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEDASYS SystemDevice
propofol sedation with the SEDASYS System
| Study group | Role | What they receive |
|---|---|---|
| SEDASYS System | Not described Receives: Device: SEDASYS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of documented responses/actions taken in response to SEDASYS System alarms (oxygen desaturation, apnea, hypotension, and bradycardia alarms)
Measured: <24 hours, i.e., for duration of study procedure
Secondary outcomes (1)
Fraction of users responses/actions to oxygen desaturation, apnea, hypotension, and/or bradycardia alarms deemed sufficient by Endpoint Adjudication Committee (EAC)
Measured: assessment of sufficient alarms will be reviewed by EAC after 100, 400, and 866 subjects completed the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study start1 Sep 2015
- Primary completion15 Jun 2016
- Study completion15 Jun 2016
Why it stopped: franchise closed; no safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conscious SedationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James F Martin, PhD, Study director, Ethicon Endo-Surgery, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573818
- Sponsor's protocol ID
- SED-14-001
- Status last verified
- Mar 2017
- First submitted
- 6 Oct 2015
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Post Approval Study of the SEDASYS System User Response to System Alarms
- ClinicalTrials.gov ID
- NCT02573818
- Acronym / sponsor ID
- SED-14-001
- Conditions
- Conscious Sedation
- Keywords
- sedation for EGD and colonoscopy procedures
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: franchise closed; no safety concerns
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 15 Jun 2016 (actual)
- Study completion
- 15 Jun 2016 (actual)
- First posted
- 12 Oct 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.
The purpose of this study is to evaluate the users' responses to the SEDASYS® System alarms during esophagogastroduodenoscopy (EGD) or colonoscopy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SEDASYS System | – | Device: SEDASYS System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects 18 years or older scheduled for colonoscopy or EGD
Key inclusion criteria (5 listed)
- American Society of Anesthesiologists (ASA) I and II
- male and female
- Scheduled for routine colonoscopy or EGD
- ≥18 years of age
- Able to read, speak, and understand English
Key exclusion criteria (10 listed)
- Physical or psychological condition which would impair trial participation, at the discretion of the PI
- BMI ≥ 35
- Pregnancy or lactation
- Known or suspected hypersensitivity to propofol or fentanyl
- Use of a fentanyl patch
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 |
|---|---|---|
| SEDASYS Systempropofol sedation with the SEDASYS System | Device | SEDASYS System |
Primary outcome
Percent of documented responses/actions taken in response to SEDASYS System alarms (oxygen desaturation, apnea, hypotension, and bradycardia alarms)
Time frame: <24 hours, i.e., for duration of study procedure
1 secondary outcome
Fraction of users responses/actions to oxygen desaturation, apnea, hypotension, and/or bradycardia alarms deemed sufficient by Endpoint Adjudication Committee (EAC)
Time frame: assessment of sufficient alarms will be reviewed by EAC after 100, 400, and 866 subjects completed the study
Results and safety
The study was stopped early (reason given: franchise closed; no safety concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- 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.
James F Martin, PhD study director
Ethicon Endo-Surgery, Inc.
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 Conscious Sedation, run by Ethicon Endo-Surgery 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 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: stopped early, as of the sponsor's last update on 24 Mar 2017. 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?
The study was stopped early (reason given: franchise closed; no safety concerns). Results are not available in the source record.
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?
Percent of documented responses/actions taken in response to SEDASYS System alarms (oxygen desaturation, apnea, hypotension, and bradycardia alarms) (time frame: <24 hours, i.e., for duration of study procedure). 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 24 Mar 2017.