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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: Completed Phase 1 study of Gastrointestinal and Gynecologic Malignancies, sponsored by Lahey Clinic.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
number of additionally visualized peritoneal lesions
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 |
What the finished NCT01944930 record still lists
NCT01944930 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01944930's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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