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NCT01944930 · ClinicalTrials.gov registry record · Phase 1
Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases
A Phase 1 study of Gastrointestinal and Gynecologic Malignancies, sponsored by Lahey Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT01944930 is a Phase 1 study of Gastrointestinal and Gynecologic Malignancies that has completed, run by Lahey Clinic. The registered enrollment target is 23 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01944930, a Phase 1 study of Gastrointestinal and Gynecologic Malignancies, has completed, sponsored by Lahey Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
Adult patients evaluated at Lahey Clinic with known or suspected gastrointestinal or gynecologic malignancies and with an indication for diagnostic laparoscopy will be offered participation in the study. The proposed study is a randomized, controlled feasibility trial with crossover design. The study's aim is to evaluate the effectiveness of laparoscopic narrow band imaging (NBI) compared to standard white-light laparoscopy for detection of peritoneal cancer metastases. Study patients will undergo laparoscopic evaluation of the peritoneal cavity using a routine white-light videolaparoscope with the capability of NBI. The order of white-light and NBI laparoscopy will be randomized for each patient (crossover design). Frozen-section histopathology biopsies will be retrieved of all suspicious-appearing abnormalities using best clinical practices. The number of detected peritoneal metastases will be compared between each diagnostic laparoscopy technique. To gauge the rate of potentially missed metastases, peritoneal cancer recurrence will be surveyed through a 1-year follow-up.
Conditions Studied
Interventions
- DEVICE Laparoscopic narrow band imaging
- DEVICE Standard white-light laparoscopy
Study Locations (1)
Massachusetts
- Lahey Clinic - Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01944930
The ClinicalTrials.gov registry entry for NCT01944930 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lahey Clinic, which has 43 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Gastrointestinal and Gynecologic Malignancies appearing as the primary indexed condition, and to 2 interventions - of which Laparoscopic narrow band imaging is the first listed.
NCT01944930 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01944930 about?
NCT01944930 is a clinical study titled "Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases". Adult patients evaluated at Lahey Clinic with known or suspected gastrointestinal or gynecologic malignancies and with an indication for diagnostic laparoscopy will be offered participation in the study. The proposed study is a randomized, controlled feasibility trial with crossover design. The stud...
What is the current status of trial NCT01944930?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2013-01. Estimated completion is 2014-09.
What conditions does trial NCT01944930 study?
This clinical trial studies the following conditions: Gastrointestinal and Gynecologic Malignancies.
What interventions are being tested in trial NCT01944930?
The interventions under investigation include: Laparoscopic narrow band imaging (DEVICE), Standard white-light laparoscopy (DEVICE).
Who is sponsoring clinical trial NCT01944930?
This trial is sponsored by Lahey Clinic, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01944930 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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