Health TrialsbyHealthPanel

Endoscopic Submucosal Dissection (ESD)

ConditionsEsophageal LesionBarrett EsophagusGastrointestinal Lesions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAdventHealth

About this trial

This registry is to evaluate the procedural and clinical outcomes in patients undergoing endoscopic submucosal dissection. All patients will receive standard of medical care and no experimental interventions will be performed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Scheduled to undergo ESD

Disqualifiers

Any contraindication to performing endoscopy

Participation in another research protocol that could interfere or influence the outcomes measures of the present study.

Trial population

Patients who present to the Center of Interventional Endoscopy for standard of care ESD procedure.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Endoscopic Submucosal Dissection

    Procedure/Surgery

    Endoscopic submucosal dissection (ESD) is an outpatient procedure to remove deep tumors from the gastrointestinal (GI) tract

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Evaluate the utility of ESD for treatment of gastrointestinal lesions

The primary endpoint of this study will be the prospective evaluation of the utility of ESD for the endoscopic treatment of GI lesions.

Time frame
12 months

Secondary outcomes

1

En-Bloc Resection Rate

1)This is the proportion of lesions that are resected en-bloc (in one piece) using ESD

Time frame
6 months
2

Complete Resection Rate

2\) This is the proportion of lesions that are completely resected (clean lateral and deep resection margins) with ESD.

Time frame
6 months
3

Curative Resection Rate

3\) This is the proportion of lesions that are considered to have been cured based on endoscopic and histological criteria

Time frame
6 months
4

Safety- Adverse Events

4\) This will be measured based on the rate of adverse events with the procedure

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AdventHealth

Lead sponsor

Source ClinicalTrials.gov
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