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NCT03193216 · ClinicalTrials.gov registry record · Phase 2

The Impact of Adjuvant Liquid Alginate on Endoscopic Ablation Therapy of Complicated Barrett's Esophagus

A Phase 2 study of Barretts Esophagus With Dysplasia, sponsored by Medical University of South Carolina.

Completed
Registry status
Phase 2
Development phase
24
Enrollment target
1
Study location

NCT03193216: Completed Phase 2 study of Barretts Esophagus With Dysplasia, sponsored by Medical University of South Carolina.

NCT03193216 is a Phase 2 study of Barretts Esophagus With Dysplasia that has completed, run by Medical University of South Carolina. The registered enrollment target is 24 participants, below the 706-participant average among 5 other Barretts Esophagus With Dysplasia trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03193216, a Phase 2 study of Barretts Esophagus With Dysplasia, has completed, sponsored by Medical University of South Carolina.

COMPLETED
Registry status
Phase 2
Development phase
24 participants
Enrollment target
1
Study location

Study Summary

This study evaluates the addition of an alginate based solution to twice daily proton pump inhibitor therapy (PPI) in patients undergoing ablative therapy for dysplastic Barrett's esophagus. The investigators hypothesize that the addition of this medication will help to achieve complete remission of Barrett's over a shorter period of time.

Primary Outcome

To compare the percentage of patients who achieved complete endoscopic eradication of dysplastic Barrett's Esophagus(BE) and non-dysplastic BE with the combination of PPI and liquid alginate solution vs. those treated with PPI alone within eighteen months from the start of treatment.

Interventions

  • DRUG Alginates

Study Locations (1)

South Carolina

  • Medical University of South Carolina - Charleston

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2017-08-25
Est. Completion 2022-01-01
Phase Phase 2

What the finished NCT03193216 record still lists

NCT03193216 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 706-participant average among 5 other Barretts Esophagus With Dysplasia trials with a reported enrollment target (97% lower).

The record links to 1 condition, with Barretts Esophagus With Dysplasia appearing as the primary indexed condition, and to 1 intervention - of which Alginates is the first listed.

NCT03193216 reports a single indexed study location in South Carolina.

Frequently Asked Questions

What is clinical trial NCT03193216 about?

NCT03193216 is a clinical study titled "The Impact of Adjuvant Liquid Alginate on Endoscopic Ablation Therapy of Complicated Barrett's Esophagus". This study evaluates the addition of an alginate based solution to twice daily proton pump inhibitor therapy (PPI) in patients undergoing ablative therapy for dysplastic Barrett's esophagus. The investigators hypothesize that the addition of this medication will help to achieve complete remission of...

What is the current status of trial NCT03193216?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2017-08-25. Estimated completion is 2022-01-01.

What conditions does trial NCT03193216 study?

This clinical trial studies the following conditions: Barretts Esophagus With Dysplasia.

What interventions are being tested in trial NCT03193216?

The interventions under investigation include: Alginates (DRUG).

Who is sponsoring clinical trial NCT03193216?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03193216 being conducted?

This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT03193216, the US trial registry maintained by the National Library of Medicine. NCT03193216 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.