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Third Eye Retroscope Randomized Clinical Evaluation (The "TERRACE" Study)


N/A
N/A
N/A
Not Enrolling
Both
Colorectal Neoplasms

Thank you

Trial Information

Third Eye Retroscope Randomized Clinical Evaluation (The "TERRACE" Study)


Inclusion Criteria:



- The patient is undergoing colonoscopy for screening, for surveillance in follow-up of
previous polypectomy or for diagnostic workup;

- The patient must understand and provide written consent for the procedure.

Exclusion Criteria:

- Patients with a history of colonic resection;

- Patients with inflammatory bowel disease;

- Patients with a personal history of polyposis syndrome;

- Patients with suspected chronic stricture potentially precluding complete
colonoscopy;

- Patients with diverticulitis or toxic megacolon;

- Patients with a history of radiation therapy to abdomen or pelvis;

- Patients who are currently enrolled in another clinical investigation in which the
intervention might compromise the safety of the patient's participation in this
study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Detection rates for adenomas and for total polyps

Outcome Time Frame:

Acute - during procedure

Safety Issue:

No

Principal Investigator

Peter D. Siersema, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMC Utrecht

Authority:

United States: Food and Drug Administration

Study ID:

Avantis TER-08-06

NCT ID:

NCT01044732

Start Date:

March 2009

Completion Date:

February 2010

Related Keywords:

  • Colorectal Neoplasms
  • Colorectal
  • Neoplasms
  • Adenomas
  • Polyps
  • Miss rates
  • Detection rates
  • Colonoscope
  • Third Eye Retroscope
  • Neoplasms
  • Colorectal Neoplasms

Name

Location

Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
Baylor University Medical CenterDallas, Texas  75246
Johns Hopkins HospitalBaltimore, Maryland  21287
Kansas City Veterans Administration Medical CenterKansas City, Missouri  64128
Bayside Endoscopy CenterProvidence, Rhode Island  02905