Cecal Intubation Success RateNCT02495480
Disposable Sheathed Gastroscopic System for Cecal Intubation
A study testing A novel disposable sheath in people with Cecal Intubation Success Rate, run by Yuqi He.
Trial summary
A novel disposable sheathed gastroscope system has been shown to be safe and more efficient in clinical practice during gastroscopy. This novel disposable sheathed endoscope system could effectively prevent cross-infection by simply taking off the contaminated sheath after examination of a patient and placing a new… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cecal Intubation Success Rate
- What is being tested?
- A novel disposable sheath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Dec 2015
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients accepted sedated colonoscopy
Who cannot join
- a request for sedation/analgesia at the start of the procedure
- previous colorectal surgery
- declining to provide informed consent
- advanced comorbidity
- coagulopathy or anticoagulant medication administered
- failure to comply with the recommended bowel preparation regimen.
About this study
Official title: A Novel Disposable Sheathed Gastroscopic System for Cecal Intubation：Safety and Efficacy in Unsedated Colonoscopies
A novel disposable sheathed gastroscope system has been shown to be safe and more efficient in clinical practice during gastroscopy. This novel disposable sheathed endoscope system could effectively prevent cross-infection by simply taking off the contaminated sheath after examination of a patient and placing a new sheath on the endoscope. In this way, investigators can save the endoscopic reprocessing time and also decrease the need for endoscopic cleaning and disinfecting equipment.
Participants may think that placing a new sheath on the endoscope can decrease the success rate of cecal intubation in patients undergoing screening colonoscopy. With a new sheath on the endoscope during scope insertion can probably increases distension of the colonic lumen and loop formation. The probable adhesion may increase the discomfort of investigators and participants. But a previous clinical study by investigators' team showed that the participants' feeling were no significant difference (Z = -1.783, P = 0.075) between sheathed and conventional groups. No significant differences were observed in optical clarity, or pathology detection rate. There were no complications, and no microbial contamination was detected. Based on this study, investigators hypothesize that compared with conventional group, placing a new sheath on the endoscope does not significantly reduce the success rate of cecal intubation in average patients.
The aim of the study is to compare the outcome of colonoscopy placing a new sheath on the endoscope versus the conventional method in average participants. The primary outcome is cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.
- Conditions
- Cecal Intubation Success Rate
- Being tested
- A novel disposable sheath
- Keywords
- disposable sheath, intubation, colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A novel disposable sheathDevice
a new sheath will be placed on the endoscope in sheathed group
| Study group | Role | What they receive |
|---|---|---|
| sheathed group | Experimental | The sterilized disposable sheath covered the outer surface of the colonoscope, then colonoscope will be performed in conventional way;a new sheath will be placed on the endoscope in sheathed group as a intervention Receives: Device: A novel disposable sheath |
| conventional group | No intervention | Colonoscopy will be performed with air insufflation during insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cecal intubation success rate
Measured: up to ten months
Secondary outcomes (1)
Pain according to a 10-point pain scale
Measured: up to ten months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cecal Intubation Success RateStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuqi He
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuqi He, General Hospital of Beijing PLA Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495480
- Sponsor's protocol ID
- GHBeijing
- Status last verified
- Jul 2015
- First submitted
- 6 Jul 2015
- Last updated
- 13 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Disposable Sheathed Gastroscopic System for Cecal Intubation：Safety and Efficacy in Unsedated Colonoscopies
- ClinicalTrials.gov ID
- NCT02495480
- Acronym / sponsor ID
- GHBeijing
- Conditions
- Cecal Intubation Success Rate
- Keywords
- disposable sheath, intubation, colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Yuqi HeUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 13 Jul 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.
A novel disposable sheathed gastroscope system has been shown to be safe and more efficient in clinical practice during gastroscopy. This novel disposable sheathed endoscope system could effectively prevent cross-infection by simply taking off the contaminated sheath after examination of a patient and placing a new sheath on the endoscope. In this way, investigators can save the endoscopic reprocessing time and also decrease the need for endoscopic cleaning and disinfecting equipment.
Participants may think that placing a new sheath on the endoscope can decrease the success rate of cecal intubation in patients undergoing screening colonoscopy. With a new sheath on the endoscope during scope insertion can probably increases distension of the colonic lumen and loop formation. The probable adhesion may increase the discomfort of investigators and participants. But a previous clinical study by investigators' team showed that the participants' feeling were no significant difference (Z = -1.783, P = 0.075) between sheathed and conventional groups. No significant differences were observed in optical clarity, or pathology detection rate. There were no complications, and no microbial contamination was detected. Based on this study, investigators hypothesize that compared with conventional group, placing a new sheath on the endoscope does not significantly reduce the success rate of cecal intubation in average patients.
The aim of the study is to compare the outcome of colonoscopy placing a new sheath on the endoscope versus the conventional method in average participants. The primary outcome is cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sheathed group | Experimental | Device: A novel disposable sheathThe sterilized disposable sheath covered the outer surface of the colonoscope, then colonoscope will be performed in conventional way;a new sheath will be placed on the endoscope in sheathed group as a intervention |
| conventional group | No intervention | –Colonoscopy will be performed with air insufflation during insertion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients accepted sedated colonoscopy
Key exclusion criteria (6 listed)
- a request for sedation/analgesia at the start of the procedure
- previous colorectal surgery
- declining to provide informed consent
- advanced comorbidity
- coagulopathy or anticoagulant medication administered
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 |
|---|---|---|
| A novel disposable sheatha new sheath will be placed on the endoscope in sheathed group | Device | sheathed group |
Primary outcome
Cecal intubation success rate
Time frame: up to ten months
1 secondary outcome
Pain according to a 10-point pain scale
Time frame: up to ten months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing A novel disposable sheath in people with Cecal Intubation Success Rate, run by Yuqi He.
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 1 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: status not confirmed, as of the sponsor's last update on 13 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Cecal intubation success rate (time frame: up to ten 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 13 Jul 2015.