Recruiting
Phase 2

Microendoscopy

Sponsor:

Anandasabapathy, Sharmila, M.D.

Code:

NCT02029937

Conditions

Suspected or Known Squamous Cell Neoplasia

Prior History of Squamous Cell Dysplasia and /or Neoplasia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Proflavine, high resolution imaging

Study Details

Brief summary:

The overall objective of this multicenter trial is to determine whether the use of a low-cost, high-resolution microendoscope during diagnostic upper endoscopy can improve the efficiency and accuracy of endoscopic screening for esophageal squamous cell neoplasia. This is a multicenter clinical trial of a novel technology, a miniaturized, lower cost (< $3, 500) microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium. This high-resolution microendoscope (HRME) was developed by our collaborators at RICE University and provides >1000X magnified images of the esophageal mucosa.

Conditions

Suspected or Known Squamous Cell Neoplasia

Prior History of Squamous Cell Dysplasia and /or Neoplasia

Study ID

NCT02029937

Start date

Jan, 2014

Status verified date

Jan, 2021

Completion date

Dec, 2021

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

All inclusive outpatients undergoing routine (standard of care) Lugol's chromoendoscopic evaluation for suspected or known squamous cell neoplasia will be enrolled as well as any outgoing patients referred to the clinic with any prior history of squamous cell dysplasia and/or neoplasia will also be considered eligible as they will serve as study population for the surveillance group.

Exclusion Criteria:

  • Allergy or prior reaction to the fluorescent contrast agent proflavine
  • Patients who are unable to give informed consent
  • Known advanced squamous cell carcinoma of the distal esophagus, or dyplastic/suspected malignant esophageal lesion greater than or equal to 2cm in size not amenable to endoscopic therapy
  • Patient unable to undergo routine endoscopy with biopsy:
  • women who are pregnant or breastfeeding
  • prothrombin time greater than 50% of control; PTT greater than 50 sec, or INR greater than 2.0
  • inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues

Study Design

Enrollment

1300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Proflavine, high resolution imaging

5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. The HRME will then be inserted through the endoscope and gently placed against the mucosa. Imaging of abnormal tissues will be performed.

no intervention: Standard of care

No invention

Interventions

Proflavine, high resolution imaging

5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. The HRME will then be inserted through the endoscope and gently placed against the mucosa. Imaging of abnormal tissues will be performed.

Primary outcome measure

  • Comparison of the efficiency of HRME+Lugol's chromoendoscopy (HRME+LC) to that of Lugol's chromoendoscopy alone (LC) for the diagnosis of esophageal squamous cell neoplasia. [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Madeleine Allman, MPH

713-798-7585allman@bcm.edu

Locations

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Sharmila Anandasabapathy, MD

More Information

Sponsor

Anandasabapathy, Sharmila, M.D.

Last update posted

Jan 14, 2021

Last verified

Jan, 2021

Keywords

  • Squamous cell neoplasia
  • Proflavine
  • Lugol's chromoendoscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Anandasabapathy, Sharmila, M.D. on 2021-01-14.