Outpatient Colonoscopy for Colorectal Cancer Screening or for Symptoms Suggestive of Colonic DiseasesCFMNCT02101099
Effect of Anesthesia on Force Application During Colonoscopy
An observational study of Outpatient Colonoscopy for Colorectal Cancer Screening or for Symptoms Suggestive of Colonic Diseases, run by Artann Laboratories at 3 sites in United States.
Trial summary
The aim of the study is to determine if more force is used during colonoscopy when patients receive monitored anesthesia with propofol versus conscious sedation. Force measurements will be performed using the colonoscopy force monitor (CFM). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Outpatient Colonoscopy for Colorectal Cancer Screening or for Symptoms Suggestive of Colonic Diseases
- What is being tested?
- Colonoscopy Force Monitor
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2014to Dec 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult male and female patients between the ages of 30 and 75 presenting to the participating sites for screening or diagnostic colonoscopy to be performed by any of the investigators will be considered for inclusion.
Who may be able to join
- Male or female
- Age: 30-75 years
- ASA Class I or II
- All ethnic and racial groups will be included
Who cannot join
- Colonic pathology that in the opinion of the endoscopist could interfere with the colonoscopy. Examples include: colonic stricture, poor preparation, obstructing tumor.
- Specific pathology that would limit the extent of examination
- ASA class 3 or greater
- Pregnancy
- Monitored anesthesia using propofol for sedation.
- Vulnerable subjects. Students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Chevy Chase Endoscopy Center
Chevy Chase, Maryland, 20815
Univeristy of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Georgetown University Medical Center, Gastroenterology
Washington D.C., District of Columbia, 20057
About this study
The aim of the study is to determine if more force is used during colonoscopy when patients receive monitored anesthesia with propofol versus conscious sedation. Force measurements will be performed using the colonoscopy force monitor (CFM). This device measures the magnitude and direction of force applied to the insertion tube of a standard colonoscope during colonoscopy.
Read the detailed description
Randomized factorial design of colonoscopy with either propofol administered anesthesia or conscious sedation. Twelve experienced endoscopists from community and academic centers will perform colonoscopy using either propofol or conscious sedation on a group of 12 patients for each endoscopist for a study total of 144 patients. An equal number of male and female patients will be included in each group.
- Being tested
- Colonoscopy Force Monitor
- Keywords
- Colonoscopy, Force, Monitor, Endoscopist, Conscious, Sedation, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy Force MonitorDevice
Also called CFM
Use of Colonoscopy Force Monitoring device (CFM) to measure forces applied to the colonoscope during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing colonoscopy | Patients who are undergoing outpatient colonoscopy for colorectal cancer screening or for symptoms suggestive of colonic diseases. Receives: Device: Colonoscopy Force Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak push force is increased in patients receiving propofol as compared to conscious sedation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outpatient Colonoscopy for Colorectal Cancer Screening or for Symptoms Suggestive of Colonic DiseasesStudies 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artann Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Capital Digestive Care, LLC, University of Pennsylvania, Georgetown University
- Responsible party
- Sponsor
- Investigators
- Louis Y Korman, M.D., Principal investigator, Capital Digestive Care, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101099
- Sponsor's protocol ID
- CFM-04
- Other IDs
- 5R44DK068936
- Acronym
- CFM
- Status last verified
- Jul 2016
- First submitted
- 28 Mar 2014
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anesthesia on Force Application During Colonoscopy
- ClinicalTrials.gov ID
- NCT02101099
- Acronym / sponsor ID
- CFM / CFM-04
- Keywords
- Colonoscopy, Force, Monitor, Endoscopist, Conscious, Sedation, Propofol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Artann LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Capital Digestive Care, LLC, University of Pennsylvania, Georgetown University
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Apr 2014 (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 aim of the study is to determine if more force is used during colonoscopy when patients receive monitored anesthesia with propofol versus conscious sedation. Force measurements will be performed using the colonoscopy force monitor (CFM). This device measures the magnitude and direction of force applied to the insertion tube of a standard colonoscope during colonoscopy.
Detailed description
Randomized factorial design of colonoscopy with either propofol administered anesthesia or conscious sedation. Twelve experienced endoscopists from community and academic centers will perform colonoscopy using either propofol or conscious sedation on a group of 12 patients for each endoscopist for a study total of 144 patients. An equal number of male and female patients will be included in each group.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing colonoscopy | – | Device: Colonoscopy Force MonitorPatients who are undergoing outpatient colonoscopy for colorectal cancer screening or for symptoms suggestive of colonic diseases. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult male and female patients between the ages of 30 and 75 presenting to the participating sites for screening or diagnostic colonoscopy to be performed by any of the investigators will be considered for inclusion.
Key inclusion criteria (4 listed)
- Male or female
- Age: 30-75 years
- ASA Class I or II
- All ethnic and racial groups will be included
Key exclusion criteria (6 listed)
- Colonic pathology that in the opinion of the endoscopist could interfere with the colonoscopy. Examples include: colonic stricture, poor preparation, obstructing tumor.
- Specific pathology that would limit the extent of examination
- ASA class 3 or greater
- Pregnancy
- Monitored anesthesia using propofol for sedation.
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 |
|---|---|---|
| Colonoscopy Force MonitorAlso: CFMUse of Colonoscopy Force Monitoring device (CFM) to measure forces applied to the colonoscope during the procedure. | Device | Patients undergoing colonoscopy |
Primary outcome
Peak push force is increased in patients receiving propofol as compared to conscious sedation.
Time frame: 6 months
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 12 Jul 2016.
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.
Louis Y Korman, M.D. principal investigator
Capital Digestive Care, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Outpatient Colonoscopy for Colorectal Cancer Screening or for Symptoms Suggestive of Colonic Diseases, run by Artann Laboratories at 3 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 4 inclusion and 6 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 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Peak push force is increased in patients receiving propofol as compared to conscious sedation. (time frame: 6 months). 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 12 Jul 2016.