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The Clinical Application of MCCES in Examination of Human Colon

26. august 2015 oppdatert av: Nanfang Hospital of Southern Medical University

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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510515
        • Rekruttering
        • Nanfang Hospital of Southern Medical University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: MCCES
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.
Fremgangsmåte: magnetic-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.
Aktiv komparator: Colonoscopy
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.
Fremgangsmåte: Colonoscopy
  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.
Andre navn:
  • colonoscope

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maneuverability
Tidsramme: 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.
From the MCCES examination began until the capsule excreted, an expected average of 24h

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Migration length of anus direction
Tidsramme: 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.
From the MCCES examination began until the capsule excreted, an expected average of 24h
The movement of mouth direction
Tidsramme: 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.
From the MCCES examination began until the capsule excreted, an expected average of 24h
Nidus of colon
Tidsramme: During the procedure
From date of the examination until the date of pathological diagnosis, an expected average of 7 days
During the procedure
The level of cleanliness
Tidsramme: 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).
From the MCCES examination began until the capsule excreted, an expected average of 24h
Procedure related complication
Tidsramme: From the day of the examination until the follow up ended ,access up to 7 days.
Perforation, capsule retention, abdominal pain and so .etc.
From the day of the examination until the follow up ended ,access up to 7 days.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Nanfang Hospital of Southern Medical University

Etterforskere

  • Hovedetterforsker: Bo Jiang, doctor, Nanfang Hospital of Southern Medical University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2015

Primær fullføring (Forventet)

1. september 2015

Studiet fullført (Forventet)

1. september 2015

Datoer for studieregistrering

Først innsendt

24. august 2015

Først innsendt som oppfylte QC-kriteriene

26. august 2015

Først lagt ut (Anslag)

31. august 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

31. august 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. august 2015

Sist bekreftet

1. august 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NFEK-2015-046

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