Abdominal Pain, Diarrhea, Hematochezia
Conditions
Keywords
colon capsule, magnetic, maneuverability, colonoscopy
Brief 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.
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.
Interventions
PROCEDUREmagnetic-controlled capsule endoscopy system
1. 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.
PROCEDUREColonoscopy
1. 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.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients who repeatedly have the symptom such as abdominal pain, diarrhea, hematochezia and so on, or * Patients who volunteer to the colonoscopy screening.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maneuverability | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Migration length of anus direction | From the MCCES examination began until the capsule excreted, an expected average of 24h | 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. |
| The movement of mouth direction | From the MCCES examination began until the capsule excreted, an expected average of 24h | 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. |
| Nidus of colon | During the procedure | From date of the examination until the date of pathological diagnosis, an expected average of 7 days |
| The level of cleanliness | From the MCCES examination began until the capsule excreted, an expected average of 24h | 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). |
| Procedure related complication | From the day of the examination until the follow up ended ,access up to 7 days. | Perforation, capsule retention, abdominal pain and so .etc. |
Countries
China
Contacts
Primary ContactHongxiang Gu, doctor
Backup ContactHuiling Zheng, master
Outcome results
None listed