ColonoscopyPhase 3NCT00452426

Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy

A Phase 3 study testing Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System) and benzodiazepines and opioid sedation in people with Colonoscopy and Endoscopy, Digestive System, run by Ethicon Endo-Surgery at 7 sites 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Colonoscopy, Endoscopy, Digestive System, Conscious Sedation
What is being tested?: Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System) and benzodiazepines and opioid sedation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,000 participants
Where: 7 sitesUnited States
Study dates: Mar 2007to Oct 2007
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥ 18 years old
Able to comprehend, sign, and date the written informed consent form
English as primary language
Undergoing a non-emergent EGD or colonoscopy
Have taken nothing by mouth for a minimum of 6 hours prior to the study procedure
American Society of Anesthesiologists (ASA) Class I, II or III

Who cannot join

Allergy or inability to tolerate study medications or components of study medications
Investigator anticipates greater than 45 minute procedure time due to known anatomical difficulty
Currently using a fentanyl patch
History of diagnosed sleep apnea
History of diagnosed gastroparesis
Baseline oxygen saturation < 90% (room air)

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Pregnant or nursing females
Body mass index (BMI) ≥ 35
Participation in a clinical trial within the past 30 days.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Charlottesville Medical Research
Charlottesville, Virginia, 22911
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Fayetteville Gastroenterology Associates, PA
Fayetteville, North Carolina, 28304
Nashville Medical Research Institute
Nashville, Tennessee, 37205
Digestive Health Specialists
Tacoma, Washington, 98405
Metropolitan Gastroenterology Group, PC
Washington D.C., District of Columbia, 20006
Digestive Health Specialists, PA
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Multi-center Pivotal Clinical Trial to Compare the Safety and Effectiveness of Procedural Sedation in GI Endoscopy: A Computer-Assisted Personalized Sedation (CAPS) Device Versus Current Standard of Care

Patients routinely receive sedation during a colonoscopy or upper endoscopy (esophagogastroduodenoscopy; EGD) procedure. Propofol is a sedative that can be used during these procedures. The purpose of this study is to determine if this CAPS device enables a physician/registered nurse (RN) team to safely and effectively administer propofol sedation during colonoscopy or EGD procedures relative to current sedation practices.

Conditions: Colonoscopy, Endoscopy, Digestive System, Conscious Sedation
Being tested: Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System), benzodiazepines and opioid sedation
Keywords: Propofol, Diprivan, Colonoscopy, Endoscopy, Digestive System, Conscious Sedation

What participants receive

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

Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System)Device
propofol sedation per device instructions for use
benzodiazepines and opioid sedationOther
per site's current standard of care

Study groups in NCT00452426
Study group	Role	What they receive
Sedation System	Experimental	Computer-Assisted Personalized Sedation (CAPS) device used for delivery of sedation Receives: Device: Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System)
Current Standard of Care	Active comparator	Site's current standard used for delivery of sedation Receives: Other: benzodiazepines and opioid sedation

What is being measured

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

Area Under the Curve for Oxygen Desaturation (AUCDesat)
AUCDesat measures desaturation as a function of incidence, magnitude, and duration. AUCDesat is the difference between the threshold and actual oxygen saturation measured every second. The total area below the 90% threshold is summated to determine AUCDesat in units of seconds*percent.
Measured: From administration of initial drug dose until subject recovered from effects of sedation

Secondary outcomes (4)

Duration of Deep Sedation/General Anesthesia
Duration of Modified Observers Assessment of Alertness and Sedation (MOAA/S)score of 0 or 1 MOAA/S is a scale of numbers ranging from 0-5, 5 being defined as being awake or minimally sedatied, and 0 defined as being at the deepest level of sedation (general anethesia). The mean MOAA/S score was the sum of each subject's scores during the procedure divided by the number of non-missing scores.
Measured: From first dose until subject recovered from effects of sedation
Patient Satisfaction
Patient Satisfaction with Sedation Instrument (PSSI) is a scale measuring patient satisfactin with the sedation they received. This validated scale consists of 16 questions that are scored and converted to a 0-100 scale, where 100 represented the most satisfied.
Measured: 24-48 hours post sedation
Clinician Satisfaction
Clinician Satisfaction with Sedation Instrument (CSSI) is a scale measuring the clinician satisfactin with the sedation they delivered. This validated scale consists of 16 questions that are scored and converted to a 0-100 scale, where 100 represented the most satisfied.
Measured: Post procedure
Recovery Time (From Sedation)
Recovery time- time for patient to reach first of two consecutive MOAA/S of 5 from the time scope was removed.
Measured: from "scope out" until first of two consecutive MOAA/S scores of 5

Timeline

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

Mar 2007Oct 2007

First posted27 Mar 2007 (estimated)
Study startMar 2007
Primary completionOct 2007
Study completionOct 2007

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ColonoscopyStudies 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 3
Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00452426
Sponsor's protocol ID: CI-06-0004
Status last verified: Dec 2010
First submitted: 26 Mar 2007
Last updated: 25 Jan 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Pambianco DJ, Vargo JJ, Pruitt RE, Hardi R, Martin JF. Computer-assisted personalized sedation for upper endoscopy and colonoscopy: a comparative, multicenter randomized study. Gastrointest Endosc. 2011 Apr;73(4):765-72. doi: 10.1016/j.gie.2010.10.031. Epub 2010 Dec 18.
PubMed 21168841

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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Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-center Pivotal Clinical Trial to Compare the Safety and Effectiveness of Procedural Sedation in GI Endoscopy: A Computer-Assisted Personalized Sedation (CAPS) Device Versus Current Standard of Care
ClinicalTrials.gov ID: NCT00452426
Acronym / sponsor ID: CI-06-0004
Conditions: Colonoscopy, Endoscopy, Digestive System, Conscious Sedation
Keywords: Propofol, Diprivan, Colonoscopy, Endoscopy, Digestive System, Conscious Sedation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,000 participants (actual)
Lead sponsor: Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Oct 2007 (actual)
Study completion: Oct 2007 (actual)
First posted: 27 Mar 2007 (estimated)
Results: Posted 25 Jan 2011

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: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sedation System	Experimental	Device: Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System)Computer-Assisted Personalized Sedation (CAPS) device used for delivery of sedation
Current Standard of Care	Active comparator	Other: benzodiazepines and opioid sedationSite's current standard used for delivery of sedation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

≥ 18 years old
Able to comprehend, sign, and date the written informed consent form
English as primary language
Undergoing a non-emergent EGD or colonoscopy
Have taken nothing by mouth for a minimum of 6 hours prior to the study procedure

Key exclusion criteria (9 listed)

Allergy or inability to tolerate study medications or components of study medications
Investigator anticipates greater than 45 minute procedure time due to known anatomical difficulty
Currently using a fentanyl patch
History of diagnosed sleep apnea
History of diagnosed gastroparesis

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
Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System)propofol sedation per device instructions for use	Device	Sedation System
benzodiazepines and opioid sedationper site's current standard of care	Other	Current Standard of Care

Primary outcome

Area Under the Curve for Oxygen Desaturation (AUCDesat)
Time frame: From administration of initial drug dose until subject recovered from effects of sedation
AUCDesat measures desaturation as a function of incidence, magnitude, and duration. AUCDesat is the difference between the threshold and actual oxygen saturation measured every second. The total area below the 90% threshold is summated to determine AUCDesat in units of seconds*percent.

4 secondary outcomes

Duration of Deep Sedation/General Anesthesia
Time frame: From first dose until subject recovered from effects of sedation
Patient Satisfaction
Time frame: 24-48 hours post sedation
Clinician Satisfaction
Time frame: Post procedure
Recovery Time (From Sedation)
Time frame: from "scope out" until first of two consecutive MOAA/S scores of 5

Results and safety

Results posted to the registry on 25 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sedation System	496	489
Current Standard of Care	504	493

Primary outcome: Area Under the Curve for Oxygen Desaturation (AUCDesat)

Time frame: From administration of initial drug dose until subject recovered from effects of sedation. Mean (95% Confidence Interval). Unit: seconds*percent of oxygen desaturation

Measure	Sedation System n = 491	Current Standard of Care n = 486
Value	23.6 (10.8 to 36.4)	88.0 (48.6 to 127.5)

Sedation System vs Current Standard of Care: p = 0.028, ANOVA

Population analysed: This analysis was intention to treat (ITT) which is all subjects who enrolled and had data avaiable. The differences in total subjects enrolled and subjects analyzed are due to missing data.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sedation System	0 of 496 (0%)	1 of 489 (0.2%)	Not reported
Current Standard of Care	1 of 504 (0.2%)	27 of 504 (5.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21168841Pambianco DJ, Vargo JJ, Pruitt RE, Hardi R, Martin JF. Computer-assisted personalized sedation for upper endoscopy and colonoscopy: a comparative, multicenter randomized study. Gastrointest Endosc. 2011 Apr;73(4):765-72. doi: 10.1016/j.gie.2010.10.031. Epub 2010 Dec 18.

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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 Martin, PhD study director

Ethicon Endo-Surgery, Inc.

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

Questions about this trial

What is this clinical trial studying?

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 6 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 25 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2011). 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?

Area Under the Curve for Oxygen Desaturation (AUCDesat) (time frame: From administration of initial drug dose until subject recovered from effects of sedation). 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 NCT00452426, which also lists 1 linked publication.

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 Jan 2011.