An interventional study of Tethered Capsule Endomicroscopy (TCE) in Anal Canal, sponsored by Massachusetts General Hospital. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Device feasibility
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The purpose of this study is to evaluate the feasibility and tolerability of the Optical Coherence Tomography (OCT) capsule during routine High Resolution Anoscopy (HRA) at Massachusetts General Hospital (MGH).
Using the Optical Coherence Tomography (OCT) tethered capsule to image the anal canal during routine HRA appointments the investigators will compare OCT image features to available histopathologic diagnoses of anal lesions. The primary outcome will be to determine whether OCT imaging can reliably detect dysplasia in the anal canal.
Massachusetts General Hospital is the lead sponsor of 2,589 studies on the registry; 447 are open to participants now.
Of its 223 completed or terminated interventional studies of FDA-regulated products, 168 (75%) have results posted.
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A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Tethered Capsule Endomicroscopy (TCE)
Obtaining Optical Coherence Tomography images of the anal canal to evaluate feasibility and tolerability to detect dysplasia in the anal canal
OCT imaging of the anal canal
OCT images will be collected of the anal canal. Images will then be reviewed by expert OCT reader(s) to identify signs of dysplasia. This is a qualitative assessment as this imaging technique is novel to have standard quality grading.
Time frame: Imaging data is collected during the procedure, and analyzed within 1 year of collection
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Dec 2028, 26 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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