Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population
The goal of this clinical trial is to learn if the Gixam device effectively identifies persons with pre-cancer or cancer in the colon and rectum in adults aged 45-84 that are of average risk to develop colorectal cancer and have received a negative result on a Fecal Immunochemical Test (FIT). The main questions it aims to answer are:
- Is the Gixam Device effective in identifying persons with pre-cancer or cancer in the colon and rectum that have received a negative FIT result?
- Is the use of the Gixam device safe?
Gixam test result will be compared to the findings of a standard of care screening colonoscopy.
Study participants will:
- Undergo the Gixam test
- Take a FIT at home and ship to a laboratory.
- Undergo a standard of care screening colonoscopy.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Alabama
-
Dothan, Alabama, Förenta staterna, 36301
- Rekrytering
- Digestive Health Specialist
-
Kontakt:
- Dawn Barnes
- Telefonnummer: 334-305-2406
- E-post: dbarnes@digestivepros.com
-
Mobile, Alabama, Förenta staterna, 36606
- Rekrytering
- East View Medical Research, LLC
-
Kontakt:
- Alana Smith Gorcey
- Telefonnummer: 251-385-9004
- E-post: asmithgorcey@eastviewmr.com
-
-
California
-
Lancaster, California, Förenta staterna, 93534
- Rekrytering
- Gastro Care Institute
-
Kontakt:
- Ruben Vargas
- Telefonnummer: 661-520-9944
- E-post: Rvargas@gciav.com
-
-
Florida
-
Orlando, Florida, Förenta staterna, 32835
- Rekrytering
- Orlando Gastroenterology, PA
-
Kontakt:
- Shivani Sriprashad
- Telefonnummer: 407-445-9224
- E-post: shivani.sriprashad@orlandogastropa.com
-
-
Illinois
-
Northbrook, Illinois, Förenta staterna, 60062
- Aktiv, inte rekryterande
- Comprehensive Gastrointestinal Health, LLC
-
-
New York
-
Carmel, New York, Förenta staterna, 10549
- Rekrytering
- Westchester Putnam Gastro
-
Kontakt:
- MarieLucia Salisbury
- Telefonnummer: 845 278 5223
- E-post: msalisbury@putnamgi.com
-
New York, New York, Förenta staterna, 10016
- Rekrytering
- NYU Langone Health
-
Kontakt:
- Allyson Yang
- Telefonnummer: (212)-263-0473
- E-post: Allyson.Yang@nyulangone.org
-
-
Ohio
-
Mentor, Ohio, Förenta staterna, 44060
- Rekrytering
- Great Lakes Gastroenterology Research, LLC
-
Kontakt:
- Christy DeJohn
- Telefonnummer: 440-205-1225
- E-post: christyd@greatlakesgastro.net
-
-
Virginia
-
Lynchburg, Virginia, Förenta staterna, 24502
- Rekrytering
- Blue Ridge Medical Research
-
Kontakt:
- Heather Wilson
- Telefonnummer: 434-455-8659
- E-post: heather.wilson@gastrocentralva.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Participants aged ≥45 - ≤84 years.
- Able to provide a signed informed consent.
- Considered by a physician or healthcare provider as being of 'average risk' for CRC.
- Scheduled for a screening colonoscopy at investigation site.
Exclusion Criteria:
-
Undergoing colonoscopy for investigation of symptoms.
-
Has undergone colonoscopy within preceding nine (9) years except for a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention.
-
Positive FIT or Fecal Occult Blood Test (FOBT) result within the preceding eleven (11) months.
-
Positive Cologuard, Sheild, ColoSense or Epi proColon test within the preceding three (3) years.
-
History of colorectal cancer.
-
Family history of colorectal cancer, defined as having one or more first- degree relatives (parent, sibling, or child) with CRC at any age.
-
Participant has a diagnosis or medical / family history of any of the following conditions, including:
- Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome)
- Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome")
- Other hereditary cancer syndromes including but not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis.
-
Participant has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
-
Participants with a disability to extend their tongue.
-
Participants with tongue tremor.
-
Participants with tongue piercing.
-
Participants that had a dental visit in the 7 days prior to the Gixam test.
-
Participants that have taken antibiotics or anti-fungal medications in the 14 days prior to the Gixam test.
-
Participants that have taken probiotics in the 14 days prior to the Gixam test.
-
Participant is pregnant.
-
Participant has any condition that in the opinion of the Investigator should preclude participation in the study.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Intervention arm
All enrolled participants will undergo the same intervention: Gixam test, FIT, and screening colonoscopy |
All participant will undergo the Gixam test per device instructions for use FIT kit will be handed out to the study participant, who will later sample stool at home and mail the specimen to a reference laboratory for analysis. All participants will undergo a standard of care screening colonoscopy which serves as the gold truth in this study |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Primary Safety Endpoint
Tidsram: From enrollment to the end of study at 30 days after
|
Number of device-related adverse events and serious adverse events. |
From enrollment to the end of study at 30 days after
|
|
Primary Efficacy Endpoints
Tidsram: Through study completion, an average of 30 days
|
Sensitivity and specificity of Gixam in participants with a negative FIT result. |
Through study completion, an average of 30 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Confirmatory Secondary Efficacy Endpoints
Tidsram: Through study completion, an average of 30 days
|
Standalone sensitivity and specificity of Gixam in general average risk population. |
Through study completion, an average of 30 days
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- CL-1009
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .