Colon Disease;NCT02160210
Ultrafine Endoscope for Colonoscopy in Diagnosis of Colorectal Diseases
A study testing Ultrafine Endoscope in people with Colon Disease; and Rectal Disease, run by Youlin Yang ,MD at 1 site in China.
Trial summary
This study is the evaluation of ultrafine endoscope (with small caliber and turning radius )for colonoscopy in decreasing abdominal pain of patients . 60 patients will be accepted in this trial. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Disease;, Rectal Disease
- What is being tested?
- Ultrafine Endoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Aug 2014
- 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 diagnostic colonoscopy;
- Subjects able to provide informed consent
Who cannot join
- Patients with poor bowel preparation;
- Contraindications of the colonoscopy;
- Prior partial or complete colectomy
Trial locations and contacts
1 site in 1 country.
China1 site
The Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
About this study
Official title: Ultrafine Endoscope for Unsedated Colonoscopy is an Effective Method to Reduce Abdominal Pain:a Prospective Randomized Study.
This study is the evaluation of ultrafine endoscope (with small caliber and turning radius )for colonoscopy in decreasing abdominal pain of patients . 60 patients will be accepted in this trial.
Read the detailed description
The aim of this study is to investigate the advantages of an endoscope with smaller turning radius and softer insert section in reducing patients' abdominal pain in colonoscopy. Transnasal gastroscope was selected in this study , because of its small caliber (5.9mm) and small turning radius . Visual analogue scale(VAS),cecum intubation time and cecum intubation rate were evaluated.
- Conditions
- Colon Disease;, Rectal Disease
- Being tested
- Ultrafine Endoscope
- Medical subject headings
- Colonic Diseases, Rectal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrafine EndoscopeDevice
Also called Transnasal gastroscope
Ultrafine endoscope reaching to the cecum within 15mins is thought to be successful.Water colonoscopy with standard colonoscope will be performed in unsuccessful subjects subsequently.
| Study group | Role | What they receive |
|---|---|---|
| Ultrafine Endoscope | Experimental | The ultrafine endoscope for colonoscopy with water method is performed in screening the colorectal diseases. Receives: Device: Ultrafine Endoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS abdominal pain scores
VAS abdominal pain scores include pain scores in the insertion phase of splenic flexure,hepatic flexure,and ileocecal junction.(0=no pain and 10=most severe pain imaginable).
Measured: up to two months
Secondary outcomes (4)
Cecum intubation time
Insertion time from rectum to reach the cecum.
Measured: up to two months
The time to reach the splenic flexure
Insertion time from rectum to reach the flexure.
Measured: up to two months
The time to reach the hepatic flexure
Insertion time from rectum to hepatic flexure.
Measured: up to two months
The success rate of the cecal intubation within 15 minutes
Percentage of successful colonoscopy (insertion of ultrafine endoscope into cecum within 15 minutes).
Measured: up to two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Disease;Studies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Youlin Yang ,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Youlin Yang ,MD, First Affiliated Hospital of Harbin Medical University
- Investigators
- Youlin Yang, MD, Principal investigator, Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160210
- Sponsor's protocol ID
- E-001
- Status last verified
- Jun 2014
- First submitted
- 9 Jun 2014
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrafine Endoscope for Unsedated Colonoscopy is an Effective Method to Reduce Abdominal Pain:a Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT02160210
- Acronym / sponsor ID
- E-001
- Conditions
- Colon Disease;, Rectal Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Youlin Yang ,MDUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 10 Jun 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.
This study is the evaluation of ultrafine endoscope (with small caliber and turning radius )for colonoscopy in decreasing abdominal pain of patients . 60 patients will be accepted in this trial.
Detailed description
The aim of this study is to investigate the advantages of an endoscope with smaller turning radius and softer insert section in reducing patients' abdominal pain in colonoscopy. Transnasal gastroscope was selected in this study , because of its small caliber (5.9mm) and small turning radius . Visual analogue scale(VAS),cecum intubation time and cecum intubation rate were evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrafine Endoscope | Experimental | Device: Ultrafine EndoscopeThe ultrafine endoscope for colonoscopy with water method is performed in screening the colorectal diseases. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnostic colonoscopy;
- Subjects able to provide informed consent
Key exclusion criteria (3 listed)
- Patients with poor bowel preparation;
- Contraindications of the colonoscopy;
- Prior partial or complete colectomy
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 |
|---|---|---|
| Ultrafine EndoscopeAlso: Transnasal gastroscopeUltrafine endoscope reaching to the cecum within 15mins is thought to be successful.Water colonoscopy with standard colonoscope will be performed in unsuccessful subjects subsequently. | Device | Ultrafine Endoscope |
Primary outcome
VAS abdominal pain scores
Time frame: up to two months
VAS abdominal pain scores include pain scores in the insertion phase of splenic flexure,hepatic flexure,and ileocecal junction.(0=no pain and 10=most severe pain imaginable).
4 secondary outcomes
Cecum intubation time
Time frame: up to two months
The time to reach the splenic flexure
Time frame: up to two months
The time to reach the hepatic flexure
Time frame: up to two months
The success rate of the cecal intubation within 15 minutes
Time frame: up to two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2014.
Related trials for Colon Disease;
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Youlin Yang, MD principal investigator
Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical 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 Ultrafine Endoscope in people with Colon Disease; and Rectal Disease, run by Youlin Yang ,MD at 1 site in China.
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 2 inclusion and 3 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 10 Jun 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 China. 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?
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?
VAS abdominal pain scores (time frame: up to two 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 10 Jun 2014.