PolypsNCT00553436
Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy
A study testing Tissue Apposition System (TAS) Device in people with Polyps, run by Ethicon Endo-Surgery at 1 site in United States.
Trial summary
The purpose of this study is to show that the surgical site in the bowel wall can be sewn closed in the colon or intestine, with a new sewing device after removal of a benign polyp according to standard of care. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Polyps
- What is being tested?
- Tissue Apposition System (TAS) Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Apr 2009
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 21 years of age;
- Willing to give consent and comply with evaluation and treatment schedule;
- Approved for polypectomy per standard preoperative endoscopic evaluation;
- Established indication for a procedure greater than colonoscopy and colonic polypectomy. This will include polyps not suitable for current practice (snare procedure) endoscopic resection by nature of size or location, in which an intestinal resection, laparoscopic-assisted polypectomy is required;
- Surgical area viewable with laparoscopy.
Who cannot join
- Physical or psychological condition which would impair study participation;
- Unable or unwilling to attend follow-up visits and examinations;
- Concurrent surgical procedure;
- Pregnancy;
- A polyp which appears to be an invasive cancer, even with negative pathology;
- A polyp with biopsies suspicious for invasive cancer;
- Participation in any other investigational device or drug study within 30 days prior to enrollment; or
- Any condition which precludes compliance with the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals, Case Medical Center
Cleveland, Ohio, 44106
About this study
The purpose of this study is to show that the surgical site in the bowel wall can be sewn closed in the colon or intestine, with a new sewing device after removal of a benign polyp according to standard of care.
Read the detailed description
Polypectomy is the medical term for removing polyps. Polyps are abnormal like growths that protrude into the lining of the bowel. Because a polyp cannot always be removed by a snare, the usual and simplest method, (for example, it may be too flat), a doctor (colorectal surgeon) may perform a polypectomy using a technique called Endoscopic Mucosal Resection (EMR). Endoscopic Mucosal Resection (EMR)is based on the concept that endoscopy (looking at the inside of your colon with an instrument called a colonoscope) provides visualization and access to the innermost lining of the gastrointestinal tract, where a polyp originates. The Endoscopic Mucosal Resection (EMR)performed during this study will be standard of care according to the current practice at University Hospitals of Cleveland.
Following polyp removal, the study procedure will be performed. A medical device is being evaluated to help with this procedure by closing the wound that remains after the polyp is removed without performing an open surgical operation. This involves suturing (sewing) the tissue back together with a Tissue Apposition System (TAS). This is also called tissue approximation. The sewing device being evaluated has been cleared by the Food and Drug Administration (FDA).
Up to 20 men and women, at least 21 years of age, requiring removal of a colonic or rectal polyp that cannot be removed by traditional colonic polypectomy, will be asked to enroll in the study. Following polyp removal, these patients will have the remaining tissue area closed using the study sewing device. Participation in this study will last approximately three months.
- Conditions
- Polyps
- Being tested
- Tissue Apposition System (TAS) Device
- Keywords
- colon, rectum, polyp, EMR, Established indication for a procedure greater than colonoscopy and colonic polypectomy
- Medical subject headings
- Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Apposition System (TAS) DeviceDevice
Closure of defect following polypectomy using the Tissue Apposition System (TAS) Device.
| Study group | Role | What they receive |
|---|---|---|
| Enrolled Subjects treated with TAS device | Experimental | All enrolled subjects treated with the Tissue Apposition System (TAS) device Receives: Device: Tissue Apposition System (TAS) Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of Participants With Successful Deployment of Tissue Apposition System (TAS)
Number of enrolled subjects (participants) treated with successful deployment of the Tissue Apposition System (TAS) device.
Measured: At The Time of Surgery
Secondary outcomes (2)
Numbers of Participants With Successful Deployments of Tissue Anchors and Associated Knotting Element for Tissue Closure Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition.
The total number of participants with successful deployments of tissue anchors and associated knotting elements for tissue closure post-Endoscopic Mucosal Resection (EMR) tissue apposition and achieving defect closure.
Measured: 3 month follow-up
Number of Participants With Durable Tissue Appositions at Three Months Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition
Measured: 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionApr 2009
- Study completionApr 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PolypsStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Conor P Delaney, MD MCh PhD FRCSI FACS, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553436
- Sponsor's protocol ID
- CI-07-0004
- Other IDs
- UH IRB #07-07-08
- Status last verified
- Apr 2010
- First submitted
- 2 Nov 2007
- Last updated
- 27 Apr 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Agrawal D, Chak A, Champagne BJ, Marks JM, Delaney CP. Endoscopic mucosal resection with full-thickness closure for difficult polyps: a prospective clinical trial. Gastrointest Endosc. 2010 May;71(6):1082-8. doi: 10.1016/j.gie.2009.12.036.
PubMed 20438900
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy
- ClinicalTrials.gov ID
- NCT00553436
- Acronym / sponsor ID
- CI-07-0004
- Conditions
- Polyps
- Keywords
- colon, rectum, polyp, EMR, Established indication for a procedure greater than colonoscopy and colonic polypectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 5 Nov 2007 (estimated)
- Results
- Posted 26 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to show that the surgical site in the bowel wall can be sewn closed in the colon or intestine, with a new sewing device after removal of a benign polyp according to standard of care.
Detailed description
Polypectomy is the medical term for removing polyps. Polyps are abnormal like growths that protrude into the lining of the bowel. Because a polyp cannot always be removed by a snare, the usual and simplest method, (for example, it may be too flat), a doctor (colorectal surgeon) may perform a polypectomy using a technique called Endoscopic Mucosal Resection (EMR). Endoscopic Mucosal Resection (EMR)is based on the concept that endoscopy (looking at the inside of your colon with an instrument called a colonoscope) provides visualization and access to the innermost lining of the gastrointestinal tract, where a polyp originates. The Endoscopic Mucosal Resection (EMR)performed during this study will be standard of care according to the current practice at University Hospitals of Cleveland.
Following polyp removal, the study procedure will be performed. A medical device is being evaluated to help with this procedure by closing the wound that remains after the polyp is removed without performing an open surgical operation. This involves suturing (sewing) the tissue back together with a Tissue Apposition System (TAS). This is also called tissue approximation. The sewing device being evaluated has been cleared by the Food and Drug Administration (FDA).
Up to 20 men and women, at least 21 years of age, requiring removal of a colonic or rectal polyp that cannot be removed by traditional colonic polypectomy, will be asked to enroll in the study. Following polyp removal, these patients will have the remaining tissue area closed using the study sewing device. Participation in this study will last approximately three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled Subjects treated with TAS device | Experimental | Device: Tissue Apposition System (TAS) DeviceAll enrolled subjects treated with the Tissue Apposition System (TAS) device |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 21 years of age;
- Willing to give consent and comply with evaluation and treatment schedule;
- Approved for polypectomy per standard preoperative endoscopic evaluation;
- Established indication for a procedure greater than colonoscopy and colonic polypectomy. This will include polyps not suitable for current practice (snare procedure) endoscopic resection by nature of size or location, in which an intestinal resection, laparoscopic-assisted polypectomy is required;
- Surgical area viewable with laparoscopy.
Key exclusion criteria (8 listed)
- Physical or psychological condition which would impair study participation;
- Unable or unwilling to attend follow-up visits and examinations;
- Concurrent surgical procedure;
- Pregnancy;
- A polyp which appears to be an invasive cancer, even with negative pathology;
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 |
|---|---|---|
| Tissue Apposition System (TAS) DeviceClosure of defect following polypectomy using the Tissue Apposition System (TAS) Device. | Device | Enrolled Subjects treated with TAS device |
Primary outcome
Numbers of Participants With Successful Deployment of Tissue Apposition System (TAS)
Time frame: At The Time of Surgery
Number of enrolled subjects (participants) treated with successful deployment of the Tissue Apposition System (TAS) device.
2 secondary outcomes
Numbers of Participants With Successful Deployments of Tissue Anchors and Associated Knotting Element for Tissue Closure Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition.
Time frame: 3 month follow-up
Number of Participants With Durable Tissue Appositions at Three Months Post-Endoscopic Mucosal Resection (EMR) Tissue Apposition
Time frame: 3 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20438900Agrawal D, Chak A, Champagne BJ, Marks JM, Delaney CP. Endoscopic mucosal resection with full-thickness closure for difficult polyps: a prospective clinical trial. Gastrointest Endosc. 2010 May;71(6):1082-8. doi: 10.1016/j.gie.2009.12.036.
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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.
Conor P Delaney, MD MCh PhD FRCSI FACS principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue Apposition System (TAS) Device in people with Polyps, run by Ethicon Endo-Surgery 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 5 inclusion and 8 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 27 Apr 2010. 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?
Yes. Results are posted in the registry (first posted 26 Mar 2010). 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?
Numbers of Participants With Successful Deployment of Tissue Apposition System (TAS) (time frame: At The Time of Surgery). 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 NCT00553436, which also lists 1 linked publication.
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 27 Apr 2010.