Esophageal FistulaCLARITYNCT01900691

Removal of the Evolution® Esophageal Stent - Fully Covered

A study testing Evolution® Esophageal Stent - Fully Covered in people with Esophageal Fistula and Esophageal Neoplasms, run by Cook Group Incorporated at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The CLARITY study is a clinical trial approved by US FDA to study the removal of the Evolution® Esophageal Stent-Fully Covered in malignant and benign indications. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Esophageal Fistula, Esophageal Neoplasms, Esophageal Perforation
What is being tested?: Evolution® Esophageal Stent - Fully Covered
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 11 sitesUnited States
Study dates: Sep 2013to 10 Dec 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient is diagnosed with benign or malignant stricture, fistula, perforation, or leak
Physician plans to remove the stent within the duration of study follow-up

Who cannot join

Patient is < 18 years of age
Patient is unable or unwilling to provide written informed consent or comply with follow-up schedule
Patient is pregnant, lactating, or planning on being pregnant within the next 6 months
Patient is simultaneously participating in another investigational drug or device study
Patient that is contraindicated to upper GI endoscopy and/or any procedure to be performed in conjunction with esophageal stent placement
Patient has a known hypersensitivity or contraindication to study products that, in the opinion of the investigator, cannot be adequately pre-medicated

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Emory University Hospital
Atlanta, Georgia, 30322
University of Virginia Health System
Charlottesville, Virginia, 22908
Cleveland Clinic
Cleveland, Ohio, 44195
Methodist Dallas Medical Center
Dallas, Texas, 75203
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Louisville, Division of Surgical Oncology
Louisville, Kentucky, 40202
Loyola University Medical Center
Maywood, Illinois, 60153
Froedtert Hospital
Milwaukee, Wisconsin, 53226
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Phoenix, Arizona, 85054
Harbor-University of California Los Angeles Medical Center
Torrance, California, 90502-2004

Other trials in United States

About this study

Official title: Clinical Investigation to Evaluate Removal of the Evolution® Esophageal Stent - Fully Covered

The CLARITY study is a clinical trial approved by US FDA to study the removal of the Evolution® Esophageal Stent-Fully Covered in malignant and benign indications.

Conditions: Esophageal Fistula, Esophageal Neoplasms, Esophageal Perforation, Esophageal Stenosis, Stents
Being tested: Evolution® Esophageal Stent - Fully Covered
Keywords: Esophageal Fistula, Esophageal Neoplasms, Esophageal Perforation, Esophageal Stenosis, Stents
Medical subject headings: Esophageal Fistula, Esophageal Neoplasms, Esophageal Perforation, Esophageal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Evolution® Esophageal Stent - Fully CoveredDevice
Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal

Study groups in NCT01900691
Study group	Role	What they receive
Evolution® Esophageal Stent	Experimental	Not described Receives: Device: Evolution® Esophageal Stent - Fully Covered

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With Successful Removal of Study Stent
The study design allowed for 130 patients to be enrolled to ensure that 58 patients had an attempted endoscopic stent removal between 7 days and 6 months in order to assess the primary measure as per sample size calculation. Therefore, the first 58 patients (malignant or benign lesions) with data submitted regarding attempted endoscopic stent removal are included in this outcome measure. Successful stent removal is one in which the study stent is completely removed from the patient during a single endoscopic procedure with the wire mesh integrity maintained such that the stent can be removed in one contiguous piece. Additionally, successful stent removal includes no tissue damage or hemorrhage visible during the retrieval procedure that is both related to the endoscopic stent removal and requires immediate treatment.
Measured: 7 days to 6 months

Secondary outcomes (1)

Number of Patients With Benign Indications That Achieved Clinical Success
The rate of clinical success in patients with strictures that showed improvement or relief of dysphagia symptoms or a seal sufficient to enable oral intake in patients with fistulas, perforations, or leaks.
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201310 Dec 2018

First posted16 Jul 2013 (estimated)
Study startSep 2013
Primary completion10 Dec 2018
Study completion10 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Esophageal FistulaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01900691
Sponsor's protocol ID: 11-012
Acronym: CLARITY
Status last verified: Aug 2022
First submitted: 1 Jul 2013
Last updated: 13 Sep 2022
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Esophageal Fistula trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Investigation to Evaluate Removal of the Evolution® Esophageal Stent - Fully Covered
ClinicalTrials.gov ID: NCT01900691
Acronym / sponsor ID: CLARITY / 11-012
Conditions: Esophageal Fistula, Esophageal Neoplasms, Esophageal Perforation, Esophageal Stenosis, Stents
Keywords: Esophageal Fistula, Esophageal Neoplasms, Esophageal Perforation, Esophageal Stenosis, Stents
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Cook Group IncorporatedIndustry (pharma, biotech, devices)
Study start: Sep 2013
Primary completion: 10 Dec 2018 (actual)
Study completion: 10 Dec 2018 (actual)
First posted: 16 Jul 2013 (estimated)
Results: Posted 23 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The CLARITY study is a clinical trial approved by US FDA to study the removal of the Evolution® Esophageal Stent-Fully Covered in malignant and benign indications.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Evolution® Esophageal Stent	Experimental	Device: Evolution® Esophageal Stent - Fully Covered

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patient is diagnosed with benign or malignant stricture, fistula, perforation, or leak
Physician plans to remove the stent within the duration of study follow-up

Key exclusion criteria (6 listed)

Patient is < 18 years of age
Patient is unable or unwilling to provide written informed consent or comply with follow-up schedule
Patient is pregnant, lactating, or planning on being pregnant within the next 6 months
Patient is simultaneously participating in another investigational drug or device study
Patient that is contraindicated to upper GI endoscopy and/or any procedure to be performed in conjunction with esophageal stent placement

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Evolution® Esophageal Stent - Fully CoveredPlacement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal	Device	Evolution® Esophageal Stent

Primary outcome

Number of Patients With Successful Removal of Study Stent
Time frame: 7 days to 6 months
The study design allowed for 130 patients to be enrolled to ensure that 58 patients had an attempted endoscopic stent removal between 7 days and 6 months in order to assess the primary measure as per sample size calculation. Therefore, the first 58 patients (malignant or benign lesions) with data submitted regarding attempted endoscopic stent removal are included in this outcome measure. Successful stent removal is one in which the study stent is completely removed from the patient during a single endoscopic procedure with the wire mesh integrity maintained such that the stent can be removed in one contiguous piece. Additionally, successful stent removal includes no tissue damage or hemorrhage visible during the retrieval procedure that is both related to the endoscopic stent removal and requires immediate treatment.

1 secondary outcome

Number of Patients With Benign Indications That Achieved Clinical Success
Time frame: 7 days

Results and safety

Results posted to the registry on 23 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Evolution® Esophageal Stent	130	111

Primary outcome: Number of Patients With Successful Removal of Study Stent

Time frame: 7 days to 6 months. Count of participants. Unit: Participants

Measure	Evolution® Esophageal Stent n = 58
Value	57

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months or removal of stent from patient (whichever comes first). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Evolution® Esophageal Stent	46 of 130 (35.4%)	94 of 130 (72.3%)	10 of 130

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Esophageal Fistula

Not yet recruitingPhase 2
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Not yet recruitingObservational study
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RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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RecruitingObservational study
Camera-based Endoscopy Allows Spontaneous Breathing Diagnostic Management in Neonates With Tracheoesophageal Fistula
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Enrolling by invitationObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Vargo, M.D., M.P.H. principal investigator

The Cleveland Clinic

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Evolution® Esophageal Stent - Fully Covered in people with Esophageal Fistula and Esophageal Neoplasms, run by Cook Group Incorporated at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Successful Removal of Study Stent (time frame: 7 days to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01900691.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.