Abdominal PainNCT02536144
The Clinical Application of MCCES in Examination of Human Colon
A study testing Colonoscopy in people with Abdominal Pain and Diarrhea, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
This study is to determine the feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human colon under the real time monitoring by colonoscopy in the clinical application. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Pain, Diarrhea, Hematochezia
- What is being tested?
- Colonoscopy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Sep 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who repeatedly have the symptom such as abdominal pain, diarrhea, hematochezia and so on, or
- Patients who volunteer to the colonoscopy screening.
Who cannot join
- Dysphagia or swallowing disorder,
- Congestive heart failure,
- Renal insufficiency,
- Prior major abdominal surgery of the gastrointestinal tract,
- Known or suspected bowel obstruction,
- Presence of a cardiac pacemaker or other implanted electromedical devices,
- Allergy or contraindication to the medications used in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
huiling Zheng, master, +86 15013113215, bywxling@163.com
About this study
Official title: The Clinical Application of Magnetic-controlled Capsule Endoscopy System in Examination of Human Colon
This study is to determine the feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human colon under the real time monitoring by colonoscopy in the clinical application.
Read the detailed description
Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the Western world. The screening tests include flexible sigmoidoscopy, optical colonoscopy (OC), double-contrast barium enema , or CT colonography . Such screening can reduce CRC incidence and mortality but its effectiveness depends on its quality, ease of use, and patient adherence .Colon capsule endoscopy(CCE) is being actively evaluated as an emerging complementary or alternative procedure for evaluation of the colon. magnetic -controlled capsule endoscopy system is a new ingestible colon capsule robot provided by Chongqing Jinshan Science \& Technology. While Screening the colon, the capsule is drove by magnetic-manipulator outside the body, which means it can move from the cecum to anus step by step under the control of the doctor. However, there's little data report on this colon capsule robot system in clinical application. The investigators plan to conduct this prospective study to determine the feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human colon under the real time monitoring by colonoscopy.
- Conditions
- Abdominal Pain, Diarrhea, Hematochezia
- Being tested
- magnetic-controlled capsule endoscopy system, Colonoscopy
- Keywords
- colon capsule, magnetic, maneuverability, colonoscopy
- Medical subject headings
- Abdominal Pain, Diarrhea, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic-controlled capsule endoscopy systemProcedure or surgery
- A magnetic-controlled capsule endoscopy(MCCE) included camera,magnet,batter and high polymer material shell.
- The MCCE would be turned to sleeping mode capturing picture at a rate of 0.5 frame per second after being swallowed.
- While reaching cecum, the MCCE would be turned to a working mode capturing picture at a rate of 2 frame per second.
- The MCCE would be controlled by the Magnetic-manipulator out of body to finish the motion of e rotation, somersault, Bird's-eye view, worm's eye view from cecum to anus.
ColonoscopyProcedure or surgery
Also called colonoscope
- Bowel preparation should be well done before the examination.
- A tube with illumination and camera system would insert into colon from anus.
- From the pictures captured by the camera ,the doctor would see the mucous of the colon.
| Study group | Role | What they receive |
|---|---|---|
| MCCES | Experimental | Magnetic -controlled capsule endoscopy system (MCCES) is a robot system that the capsule would be swallowed to observe the mucosa of the human alimentary canal especially the colon under the control of the magnetic-manipulator. Receives: Procedure: magnetic-controlled capsule endoscopy system |
| Colonoscopy | Active comparator | Colonoscopy has now been in use for many years to visualize and diagnose abnormalities of the colon and it is the gold standard for detecting colorectal lesions.In this study,the additional utility of the colonoscopy is to monitor the movement of the Magnetic -controlled capsule endoscopy. Receives: Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maneuverability
The Maneuverability was defined as the rotation, somersault, Bird's-eye view, worm's eye view of the capsule, and completing any motion would gain 1 point, eventually ,4 point was good,2-3 point moderate,0-1point poor.
Measured: From the MCCES examination began until the capsule excreted, an expected average of 24h
Secondary outcomes (5)
Migration length of anus direction
Migration length of anus direction was defined as how long was the distance the capsule controlled by the Magnetic-manipulator moved from cecum to anus in 25 minutes.
Measured: From the MCCES examination began until the capsule excreted, an expected average of 24h
The movement of mouth direction
The movement of mouth direction was defined as if the capsule controlled by the Magnetic-manipulator could move from any point of the colon towards mouth direction.
Measured: From the MCCES examination began until the capsule excreted, an expected average of 24h
Nidus of colon
From date of the examination until the date of pathological diagnosis, an expected average of 7 days
Measured: During the procedure
The level of cleanliness
The cleanliness of the colon was graded as excellent (No more than small bits of adherent feces),good(Small amount of feces or dark fluid,but not enough to interfere with the examination ),fair(Enough feces or dark fluid present to preclude a completely reliable examination),poor(large amount of fecal residue).
Measured: From the MCCES examination began until the capsule excreted, an expected average of 24h
Procedure related complication
Perforation, capsule retention, abdominal pain and so .etc.
Measured: From the day of the examination until the follow up ended ,access up to 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Abdominal PainStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bo Jiang, doctor, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536144
- Sponsor's protocol ID
- NFEK-2015-046
- Status last verified
- Aug 2015
- First submitted
- 24 Aug 2015
- Last updated
- 31 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Spada C, Hassan C, Ingrosso M, Repici A, Riccioni ME, Pennazio M, Pirozzi GA, Pagano N, Cesaro P, Spera G, Petruzziello L, Costamagna G. A new regimen of bowel preparation for PillCam colon capsule endoscopy: a pilot study. Dig Liver Dis. 2011 Apr;43(4):300-4. doi: 10.1016/j.dld.2010.10.005. Epub 2010 Nov 18.
PubMed 21087902Hagel AF, Gabele E, Raithel M, Hagel WH, Albrecht H, de Rossi TM, Singer C, Schneider T, Neurath MF, Farnbacher MJ. Colon capsule endoscopy: detection of colonic polyps compared with conventional colonoscopy and visualization of extracolonic pathologies. Can J Gastroenterol Hepatol. 2014 Feb;28(2):77-82. doi: 10.1155/2014/691785.
PubMed 24501724Gu H, Zheng H, Cui X, Huang Y, Jiang B. Maneuverability and safety of a magnetic-controlled capsule endoscopy system to examine the human colon under real-time monitoring by colonoscopy: a pilot study (with video). Gastrointest Endosc. 2017 Feb;85(2):438-443. doi: 10.1016/j.gie.2016.07.053. Epub 2016 Jul 29.
PubMed 27480288
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Application of Magnetic-controlled Capsule Endoscopy System in Examination of Human Colon
- ClinicalTrials.gov ID
- NCT02536144
- Acronym / sponsor ID
- NFEK-2015-046
- Conditions
- Abdominal Pain, Diarrhea, Hematochezia
- Keywords
- colon capsule, magnetic, maneuverability, colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 31 Aug 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.
This study is to determine the feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human colon under the real time monitoring by colonoscopy in the clinical application.
Detailed description
Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the Western world. The screening tests include flexible sigmoidoscopy, optical colonoscopy (OC), double-contrast barium enema , or CT colonography . Such screening can reduce CRC incidence and mortality but its effectiveness depends on its quality, ease of use, and patient adherence .Colon capsule endoscopy(CCE) is being actively evaluated as an emerging complementary or alternative procedure for evaluation of the colon. magnetic -controlled capsule endoscopy system is a new ingestible colon capsule robot provided by Chongqing Jinshan Science \& Technology. While Screening the colon, the capsule is drove by magnetic-manipulator outside the body, which means it can move from the cecum to anus step by step under the control of the doctor. However, there's little data report on this colon capsule robot system in clinical application. The investigators plan to conduct this prospective study to determine the feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human colon under the real time monitoring by colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCCES | Experimental | Procedure: magnetic-controlled capsule endoscopy systemMagnetic -controlled capsule endoscopy system (MCCES) is a robot system that the capsule would be swallowed to observe the mucosa of the human alimentary canal especially the colon under the control of the magnetic-manipulator. |
| Colonoscopy | Active comparator | Procedure: ColonoscopyColonoscopy has now been in use for many years to visualize and diagnose abnormalities of the colon and it is the gold standard for detecting colorectal lesions.In this study,the additional utility of the colonoscopy is to monitor the movement of the Magnetic -controlled capsule endoscopy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who repeatedly have the symptom such as abdominal pain, diarrhea, hematochezia and so on, or
- Patients who volunteer to the colonoscopy screening.
Key exclusion criteria (7 listed)
- Dysphagia or swallowing disorder,
- Congestive heart failure,
- Renal insufficiency,
- Prior major abdominal surgery of the gastrointestinal tract,
- Known or suspected bowel obstruction,
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 |
|---|---|---|
| magnetic-controlled capsule endoscopy system1. A magnetic-controlled capsule endoscopy(MCCE) included camera,magnet,batter and high polymer material shell. 2. The MCCE would be turned to sleeping mode capturing picture at a rate of 0.5 frame per second after being swallowed. 3. While reaching cecum, the MCCE would be turned to a working mode capturing picture at a rate of 2 frame per second. 4. The MCCE would be controlled by the Magnetic-manipulator out of body to finish the motion of e rotation, somersault, Bird's-eye view, worm's eye view from cecum to anus. | Procedure or surgery | MCCES |
| ColonoscopyAlso: colonoscope1. Bowel preparation should be well done before the examination. 2. A tube with illumination and camera system would insert into colon from anus. 3. From the pictures captured by the camera ,the doctor would see the mucous of the colon. | Procedure or surgery | Colonoscopy |
Primary outcome
Maneuverability
Time frame: From the MCCES examination began until the capsule excreted, an expected average of 24h
The Maneuverability was defined as the rotation, somersault, Bird's-eye view, worm's eye view of the capsule, and completing any motion would gain 1 point, eventually ,4 point was good,2-3 point moderate,0-1point poor.
5 secondary outcomes
Migration length of anus direction
Time frame: From the MCCES examination began until the capsule excreted, an expected average of 24h
The movement of mouth direction
Time frame: From the MCCES examination began until the capsule excreted, an expected average of 24h
Nidus of colon
Time frame: During the procedure
The level of cleanliness
Time frame: From the MCCES examination began until the capsule excreted, an expected average of 24h
Procedure related complication
Time frame: From the day of the examination until the follow up ended ,access up to 7 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2015.
- Results publication: PubMed 21087902Spada C, Hassan C, Ingrosso M, Repici A, Riccioni ME, Pennazio M, Pirozzi GA, Pagano N, Cesaro P, Spera G, Petruzziello L, Costamagna G. A new regimen of bowel preparation for PillCam colon capsule endoscopy: a pilot study. Dig Liver Dis. 2011 Apr;43(4):300-4. doi: 10.1016/j.dld.2010.10.005. Epub 2010 Nov 18.
- Results publication: PubMed 24501724Hagel AF, Gabele E, Raithel M, Hagel WH, Albrecht H, de Rossi TM, Singer C, Schneider T, Neurath MF, Farnbacher MJ. Colon capsule endoscopy: detection of colonic polyps compared with conventional colonoscopy and visualization of extracolonic pathologies. Can J Gastroenterol Hepatol. 2014 Feb;28(2):77-82. doi: 10.1155/2014/691785.
- Derived from this study: PubMed 27480288Gu H, Zheng H, Cui X, Huang Y, Jiang B. Maneuverability and safety of a magnetic-controlled capsule endoscopy system to examine the human colon under real-time monitoring by colonoscopy: a pilot study (with video). Gastrointest Endosc. 2017 Feb;85(2):438-443. doi: 10.1016/j.gie.2016.07.053. Epub 2016 Jul 29.
- Homepage of Department of Gastroenterology, Nanfang Hospital of Southern Medical UniversityLink provided by the sponsor.
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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.
Bo Jiang, doctor principal investigator
Nanfang Hospital, Southern 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 Colonoscopy in people with Abdominal Pain and Diarrhea, run by Nanfang Hospital, Southern Medical University 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 7 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 31 Aug 2015. 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?
Contact Hongxiang Gu, doctor (+86 15975625636, Redkind@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maneuverability (time frame: From the MCCES examination began until the capsule excreted, an expected average of 24h). 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 NCT02536144, which also lists 3 linked publications.
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 31 Aug 2015.