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Effectiveness and Safety of the Colonoscopy With "Visualization" Balloon

17. august 2018 oppdatert av: Sergey Kantsevoy, Mercy Medical Center

A Randomized Controlled Trial to Evaluate Effectiveness and Safety of the Colonoscopy With the "Visualization" Balloon

Colonoscopy has become the "gold standard" in detection of colonic polyps and colon cancer. However, colonoscopy causes significant abdominal discomfort and abdominal pain during and after the procedure, requiring intravenous sedation and use of analgesics. The discomfort and pain are mostly caused by air insufflation and intubation difficulties during advancement of the colonoscope in order the reach the cecum.

Study Hypothesis: Use of the "Visualization" Balloon will facilitate advancement of the colonoscope and will eliminate the need for colonic distention with the air or CO2, which can shortened the length of the procedure, reduce patient's discomfort and can decrease amount of sedatives and analgesics used during colonoscopy.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The goal of this study is to evaluate effectiveness and safety of a "Visualization" Balloon for performance of colonoscopy.

Our hypothesis is that, use of "Visualization" Balloon will decrease colonic distention, patient's discomfort, use of sedatives and analgetics during procedure and will simplify the performance of colonoscopy resulting in shortening of procedure time and increasing the rate of cecal intubation.

Specific aims of the study:

  1. To compare procedure time and effectiveness of the "Visualization" Balloon colonoscopy with traditional CO2-insufflation colonoscopy.
  2. To compare safety profiles between traditional CO2-insufflation colonoscopy and colonoscopy using the "Visualization" Balloon.

4 STUDY ENDPOINTS 4.1 Primary Outcome To compare the mean cecal intubation time achieved with "Visualization" Balloon colonoscopy, with the mean cecal intubation time achieved with standard colonoscopy using CO2 insufflation.

4.2 Secondary Outcomes

To compare "Visualization" Balloon colonoscopy with standard CO2-insufflation colonoscopy in regards of:

  1. Total amount of carbon dioxide (CO2) gas for colonic insufflation used during the procedure.
  2. Ease of colonoscope insertion.
  3. The length of the colonoscope when it reaches the cecum. 4 Colonoscope withdrawal time and total procedure time.

5. Cecal intubation rate. 6. Total dosage of analgesics and sedative during procedure. 7. Patient satisfaction: perceived pain and discomfort immediately after the procedure and in 24 hours post procedure.

8. Complications during and after colonoscopy. 9. Polyp detection rate.

Studietype

Intervensjonell

Registrering (Faktiske)

216

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Maryland
      • Baltimore, Maryland, Forente stater, 21202
        • Mercy Medical Center

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

17 år til 90 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. The patient is undergoing colonoscopy for colo-rectal cancer screening, polypectomy or for diagnostic workup.
  2. Subject is able to understand the risks and benefits of participating in the study and must be willing to sign and date the Informed Consent Form for this study approved by the Institutional Review Board (IRB.)
  3. Age from 17 to 90 years.
  4. Be willing and able to comply with the requirements of the protocol.
  5. Be willing to refrain from participating in any other investigational interventional study while enrolled in this study.
  6. Female subjects must have a negative pregnancy test within the last 24 hours timeline and have no intentions of becoming pregnant during participation in the study, or be sterilized.

Exclusion Criteria:

  1. Subjects with a history of previous colonic resection.
  2. Subjects with uncorrectable bleeding disorders (INR more than 1.5, platelet count less than 50,000).
  3. Subjects unwilling or unable to give written consent to participate in the investigation or unable to comply with the requirements of the protocol.
  4. Subjects with suspected colonic strictures potentially precluding complete colonoscopy.
  5. Subjects who received any experimental drug or device within the previous three months.
  6. Female subjects who were pregnant or lactating or were intending to become pregnant during the period of the study, or who would not use an adequate method of contraception (contraceptive pill, intra-uterine device) for the duration of the study.
  7. Subjects who possessed any psychological condition, or were under treatment for any condition which, in the opinion of the Investigator and/or consulting physicians(s), would constitute an unwarranted risk.

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: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Visualization balloon
Colonoscopy performed with the use of "Visualization" balloon
Enhet: Visualization balloon
The "Visualization" Balloon is a disposable medical device that is used during the advancement of the colonoscope inside the colon. The intended use of the "Visualization" Balloon is to help insertion of the colonoscope into the colon without the aid of gas (air or CO2) insufflation as with standard colonoscopy. The "Visualization" Balloon is inserted through the biopsy channel of the colonoscope prior to the colonoscope introduction into the rectum. The "Visualization" Balloon is an inflatable balloon that opens up the lumen of the gastrointestinal tract, thereby allowing the endoscopist to advance the endoscope inside and to view the gastrointestinal tract through the clear balloon.
Aktiv komparator: Traditional CO2-insufflation colonoscopy
Traditional colonoscopy performed with CO2 insufflation without "Visualization" balloon
Enhet: Traditional CO2 insufflation colonoscopy
Traditional colonoscopy performed with CO2 insufflation without "Visualization" balloon

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cecal intubation time
Tidsramme: Immediately
Time required to reach cecum
Immediately

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Length of colonoscope when it reaches cecum
Tidsramme: Immediately
Total length of colonoscope when it reaches cecum
Immediately
Ease of colonoscope insertion
Tidsramme: Immediate
Easy of colonoscope insertion to cecum
Immediate
Dose of analgesics and sedatives used
Tidsramme: Immediately
Dose of analgesics and sedatives used during insertion and total dose for the entire procedure
Immediately
Patient satisfaction
Tidsramme: Immediately and in 24 hours
Patient satisfaction: perceived pain and discomfort immediately after the procedure and in 24 hours post procedure.
Immediately and in 24 hours
Total procedure time
Tidsramme: Immediately
Total time required to complete colonoscopy
Immediately

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Amount of carbon dioxide used
Tidsramme: Immediately
Total amount of carbon dioxide used during colonoscopy
Immediately

Samarbeidspartnere og etterforskere

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

Sponsor

Mercy Medical Center

Etterforskere

  • Hovedetterforsker: Sergey V Kantsevoy, MD, PhD, Mercy Medical Center

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. mars 2014

Primær fullføring (Faktiske)

1. desember 2017

Studiet fullført (Faktiske)

1. desember 2017

Datoer for studieregistrering

Først innsendt

11. april 2014

Først innsendt som oppfylte QC-kriteriene

15. april 2014

Først lagt ut (Anslag)

17. april 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. august 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. august 2018

Sist bekreftet

1. august 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • VB-001

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