Esophageal NeoplasmsNCT02911363
Comparison of Captivator Tissue Cassettes vs. no Cassettes for Endoscopic Mucosal Resection in Esophageal Carcinoma
A study testing Captivator cassette in people with Esophageal Neoplasms, run by AdventHealth at 1 site in United States.
Trial summary
The main purpose of this study will be to two-fold; firstly to determine whether the use of a Captivator tissue cassette has an effect on the preservation of tissue histology (minimizing artifactual curling) , and secondly to determine whether the use of a intraprocedural cassette is practical. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- Captivator cassette
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients referred to Florida Hospital Endoscopy Unit for assessment of an esophageal lesion that require EMR
- Age ≥ 19 years
Who cannot join
- Age <19 years
- Unable to safely undergo EMR for any reason
- Coagulopathy (INR >1.6, Thrombocytopenia with platelet count <80,000/ml)
- Unable to provide consent for any reason
- Pregnancy (confirmed with Standard of Care urine pregnancy test for all women with child-bearing potential)
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Interventional Endoscopy - Florida Hospital
Orlando, Florida, 32803
About this study
Official title: Randomized Trial Comparing Captivator Tissue Cassettes vs. no Cassettes for Endoscopic Mucosal Resection in Esophageal Carcinoma
The main purpose of this study will be to two-fold; firstly to determine whether the use of a Captivator tissue cassette has an effect on the preservation of tissue histology (minimizing artifactual curling) , and secondly to determine whether the use of a intraprocedural cassette is practical. The investigators believe that this will greatly aid in elucidating the best technique for optimizing performance of EMR for esophageal lesions.
Read the detailed description
As a result of the advances in endoscopic procedures, the detection of early stage esophageal carcinoma has increased. Endoscopic mucosal resection (EMR) is an innovative technique for removal of high grade intraepithelial neoplasia/dysplasia to prevent the progression of invasive carcinoma which occurs in about a third of patients. EMR involves the endoscopic therapeutic removal of the abnormal esophageal area(s) of tissue by snare or suction, aiming to include as much of the submucosal layer as possible, which is (are) then submitted for histopathological examination for pathological diagnosis and tumor staging. Compared with esophageal biopsy, this methodology reveals more advanced tumor stages in terms of grading and vertical infiltration in 10-20% of patients. Because of the importance of histopathologic diagnosis, the specimen should be pinned on a cork or styrofoam board to prevent curling and maintain the orientation, integrity of the size and shape, and fixed in an appropriate volume of 10% formalin. Unfortunately, specimens are often not pinned as EMR specimens can be difficult and time consuming to pin because of their thickness, hence the specimen integrity (size and shape) and orientation is compromised.
Therefore the main purpose of this study will be to two-fold; firstly to determine whether the use of a Captivator tissue cassette has an effect on the preservation of tissue histology (minimizing artifactual curling) , and secondly to determine whether the use of a intraprocedural cassette is practical. The investigators believe that this will greatly aid in elucidating the best technique for optimizing performance of EMR for esophageal lesions.
- Conditions
- Esophageal Neoplasms
- Being tested
- Captivator cassette, Standard of Care
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Captivator cassetteDevice
The Captivator tissue cassette has an effect on the preservation of tissue histology.
Standard of CareOther
The specimen will be processed following the College of American Pathology Standards.
| Study group | Role | What they receive |
|---|---|---|
| Capitvator Cassette | Active comparator | The EMR specimen will be processed using the Captivator Cassette. Receives: Device: Captivator cassette |
| Standard of Care Processing | Active comparator | The EMR specimen will be prepared per Standard of Care. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological quality of the EMR specimen obtained during the procedure will be analyzed and compared to cassette vs. no cassette for pathology review.
- Captivator tissue cassette vs. no cassette
- Captivator tissue cassette with margin curling/artifact vs. Captivator tissue cassette without margin curling/artifact
- No cassette with margin curling/artifact vs. no cassette without margin curling/artifact
- Captivator tissue cassette with margin curling/artifact vs. No cassette with margin curling/artifact
Measured: 1 year
Secondary outcomes (1)
Ease of use of the Captivator tissue cassette will be comparable to Standard of Care.
Ease of use of the Captivator tissue cassette will be comparable in terms of handling the histologic specimen and will not add significant time to the intraprocedural or laboratory handling and processing.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Esophageal NeoplasmsStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shantel Hebert-Magee, MD, Principal investigator, Florida Hospital Orlando
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911363
- Sponsor's protocol ID
- 724207
- Status last verified
- Feb 2019
- First submitted
- 12 Apr 2016
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.
PubMed 23335087Devesa SS, Blot WJ, Fraumeni JF Jr. Changing patterns in the incidence of esophageal and gastric carcinoma in the United States. Cancer. 1998 Nov 15;83(10):2049-53.
PubMed 9827707Blot WJ, McLaughlin JK. The changing epidemiology of esophageal cancer. Semin Oncol. 1999 Oct;26(5 Suppl 15):2-8.
PubMed 10566604Lagergren J, Bergstrom R, Lindgren A, Nyren O. Symptomatic gastroesophageal reflux as a risk factor for esophageal adenocarcinoma. N Engl J Med. 1999 Mar 18;340(11):825-31. doi: 10.1056/NEJM199903183401101.
PubMed 10080844
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Captivator Tissue Cassettes vs. no Cassettes for Endoscopic Mucosal Resection in Esophageal Carcinoma
- ClinicalTrials.gov ID
- NCT02911363
- Acronym / sponsor ID
- 724207
- Conditions
- Esophageal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study will be to two-fold; firstly to determine whether the use of a Captivator tissue cassette has an effect on the preservation of tissue histology (minimizing artifactual curling) , and secondly to determine whether the use of a intraprocedural cassette is practical. The investigators believe that this will greatly aid in elucidating the best technique for optimizing performance of EMR for esophageal lesions.
Detailed description
As a result of the advances in endoscopic procedures, the detection of early stage esophageal carcinoma has increased. Endoscopic mucosal resection (EMR) is an innovative technique for removal of high grade intraepithelial neoplasia/dysplasia to prevent the progression of invasive carcinoma which occurs in about a third of patients. EMR involves the endoscopic therapeutic removal of the abnormal esophageal area(s) of tissue by snare or suction, aiming to include as much of the submucosal layer as possible, which is (are) then submitted for histopathological examination for pathological diagnosis and tumor staging. Compared with esophageal biopsy, this methodology reveals more advanced tumor stages in terms of grading and vertical infiltration in 10-20% of patients. Because of the importance of histopathologic diagnosis, the specimen should be pinned on a cork or styrofoam board to prevent curling and maintain the orientation, integrity of the size and shape, and fixed in an appropriate volume of 10% formalin. Unfortunately, specimens are often not pinned as EMR specimens can be difficult and time consuming to pin because of their thickness, hence the specimen integrity (size and shape) and orientation is compromised.
Therefore the main purpose of this study will be to two-fold; firstly to determine whether the use of a Captivator tissue cassette has an effect on the preservation of tissue histology (minimizing artifactual curling) , and secondly to determine whether the use of a intraprocedural cassette is practical. The investigators believe that this will greatly aid in elucidating the best technique for optimizing performance of EMR for esophageal lesions.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capitvator Cassette | Active comparator | Device: Captivator cassetteThe EMR specimen will be processed using the Captivator Cassette. |
| Standard of Care Processing | Active comparator | Other: Standard of CareThe EMR specimen will be prepared per Standard of Care. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients referred to Florida Hospital Endoscopy Unit for assessment of an esophageal lesion that require EMR
- Age ≥ 19 years
Key exclusion criteria (5 listed)
- Age <19 years
- Unable to safely undergo EMR for any reason
- Coagulopathy (INR >1.6, Thrombocytopenia with platelet count <80,000/ml)
- Unable to provide consent for any reason
- Pregnancy (confirmed with Standard of Care urine pregnancy test for all women with child-bearing potential)
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 |
|---|---|---|
| Captivator cassetteThe Captivator tissue cassette has an effect on the preservation of tissue histology. | Device | Capitvator Cassette |
| Standard of CareThe specimen will be processed following the College of American Pathology Standards. | Other | Standard of Care Processing |
Primary outcome
Histological quality of the EMR specimen obtained during the procedure will be analyzed and compared to cassette vs. no cassette for pathology review.
Time frame: 1 year
1. Captivator tissue cassette vs. no cassette 1. Captivator tissue cassette with margin curling/artifact vs. Captivator tissue cassette without margin curling/artifact 2. No cassette with margin curling/artifact vs. no cassette without margin curling/artifact 3. Captivator tissue cassette with margin curling/artifact vs. No cassette with margin curling/artifact
1 secondary outcome
Ease of use of the Captivator tissue cassette will be comparable to Standard of Care.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Background: PubMed 23335087Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.
- Background: PubMed 9827707Devesa SS, Blot WJ, Fraumeni JF Jr. Changing patterns in the incidence of esophageal and gastric carcinoma in the United States. Cancer. 1998 Nov 15;83(10):2049-53.
- Background: PubMed 10566604Blot WJ, McLaughlin JK. The changing epidemiology of esophageal cancer. Semin Oncol. 1999 Oct;26(5 Suppl 15):2-8.
- Background: PubMed 10080844Lagergren J, Bergstrom R, Lindgren A, Nyren O. Symptomatic gastroesophageal reflux as a risk factor for esophageal adenocarcinoma. N Engl J Med. 1999 Mar 18;340(11):825-31. doi: 10.1056/NEJM199903183401101.
- Individual participant dataSharing planned: No
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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.
Shantel Hebert-Magee, MD principal investigator
Florida Hospital Orlando
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Captivator cassette in people with Esophageal Neoplasms, run by AdventHealth at 1 site 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 5 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 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Histological quality of the EMR specimen obtained during the procedure will be analyzed and compared to cassette vs. no cassette for pathology review. (time frame: 1 year). 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 NCT02911363, which also lists 4 linked publications.
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 11 Feb 2019.