Health TrialsbyHealthPanel

Evaluation of the Clinical Utility of Endoscopic Closure Using a Dual Action Tissue (DAT) Clip

ConditionsGI BleedingPerforation ColonPerforation BowelPerforation DuodenalPerforated BowelFistula
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAdventHealth

About this trial

This study is designed as a multicenter prospective data recording study to document the performance of the DAT clip as part of standard medical care of patients. No experimental interventions will be performed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older.

Disqualifiers

Any contraindications to performing endoscopy.

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

Trial population

Adult patients scheduled to undergo endoscopic procedures at participating centers as medically indicated will be considered for the study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • DAT Clip

    Device

    All patients scheduled to undergo endoscopic procedures as medically indicated will be considered for the study. Data will be prospectively recorded according to the data collection form. The use of the DAT clip will be performed as medically indicated and consistent with the indications for endoscopic clipping (e.g., management of bleeding, treatment of fistulas, perforations, tissue approximation). The investigators on this project will also oversee the medical care of all patients that will participate in the study. Therefore, follow-up will be carried out as medically indicated and no clinical visits will be needed specifically for the purpose of this study.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Complete closure rate.

Cases in which complete tissue approximation is achieved with the use of the DAT clip- no substantial gaps are visible in the closure line.

Time frame
12 months

Secondary outcomes

1

Rate of Achievement of intended targeted therapy.

Defined as cases in which utilization of the DAT clip accomplished the intended treatment effect (e.g., hemostasis, perforation closure)

Time frame
12 months
2

Procedural time.

Measure of procedural time associated with the operation of the DAT clip for its intended purpose.

Time frame
12 months
3

Adverse Events

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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