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Polyp of Large IntestineNCT02245854

Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps

A study testing Exacto™ in people with Polyp of Large Intestine and Colonic Polyps, run by Istituto Clinico Humanitas at 3 sites in Italy.

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

Colorectal cancer is a major cause of morbidity and mortality in Western countries. Scientific studies have shown that endoscopic polypectomy is efficacious in preventing CRC incidence and mortality. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Exacto™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
3 sitesItaly
Study dates
Sep 2013to Aug 2014
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All consecutive patients undergoing colonoscopy, with at least one and no more than 5 polyps <10 mm.
  • The patient is at satisfactory risk to undergo abdominal surgery.
  • The patient must understand and provide written consent for the procedure.

Who cannot join

  • Patients with inflammatory bowel disease.
  • Patients undergoing standard snare resection (with cautery) of polyps larger than 10 mm.
  • Patients with a personal history of polyposis syndrome.
  • Patients with suspected chronic stricture potentially precluding complete colonoscopy.
  • Patients with diverticulitis or toxic megacolon.
  • Patients with a history of radiation therapy to abdomen or pelvis.
Show all 9Show fewer
  • Patients with a history of severe cardiovascular, pulmonary, liver or renal disease.
  • Personal history of coagulation disorders or use of anticoagulants/clopidogrel/aspirin/ticlopidine.
  • Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

  • San Gerardo Hospital

    Monza, 20052

  • Azienda Ospedaliera "Maggiore della Carità"

    Novara, 28100

  • Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital

    Rozzano, Milan, Italy, 20089

Other trials in Italy

About this study

Official title: Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Subcentimetric Colorectal Polyps: the E-scope (Efficacy and Safety of COld PolypEctomy) Trial

Colorectal cancer is a major cause of morbidity and mortality in Western countries. Scientific studies have shown that endoscopic polypectomy is efficacious in preventing CRC incidence and mortality.

Endoscopic polypectomy carries a risk of major complications, such as bleeding or bowel perforation, so that a careful balance between efficacy and safety appears to be clinically relevant.

Read more

Most of the polypectomies are performed for diminutive (<5 mm) or small (6-9 mm) lesions, which represent over 90% of all the polyps.

To minimize the risk of complications when removing <10 mm polyps, cold-polypectomy techniques - i.e. without electric current - by means of biopsy forceps or snare, have been proposed.

Although the risk of perforation is virtually excluded by cold-polypectomy, the lack of electrocautery may result in an increased risk of bleeding. The safety of cold-snare polypectomy has however been recently shown in controlled trials.

Regarding the efficacy of cold-polypectomy for subcentimetric polyps, very few studies have assessed the post-polypectomy completeness of the removal of polyp tissue (i.e. residual disease), and no studies have compared it to conventional polypectomy.

The investigators perform this study to assess both the efficacy and safety of a novel snare (Exacto™) for polyp removal.

Being tested
Exacto™
Keywords
diminutive polyps, small polyps, cold snare polypectomy, complications, bleeding
Medical subject headings
Colonic Polyps, Hemorrhage

What participants receive

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

  • Exacto™Device

    Cold snare polypectomy

Study groups in NCT02245854
Study groupRoleWhat they receive
Colonic polypsExperimentalExacto™
Receives: Device: Exacto™

What is being measured

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

  1. Percentage of complete polyp removal

    Clinical success, defined as absence of polyp tissue, either hyperplastic or adenomatous, on the margins of the polypectomy area after cold-polypectomy of subcentimetric polyps. Such assessment is performed on two biopsies performed on the polypectomy scar. The investigators will calculate the percentage (%) of complete and incomplete polypectomies with the new device.

    Measured: One year

Secondary outcomes (2)

  1. Clinical success according to size

    Clinical success (as defined in the primary end-point) according to the size class: diminutive (<5 mm) and small (6-9 mm) polyps.

    Measured: One year

  2. Post-polypectomy bleeding rates

    Post-polypectomy bleeding defined as any bleeding requiring immediate therapeutic endoscopic procedure (i.e. clipping, electrocautery) or delayed treatment, such as hospitalization or new endoscopic procedure.

    Measured: One year

Timeline

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

  1. First posted22 Sep 2014 (estimated)
  2. Study startSep 2013
  3. Primary completionApr 2014
  4. Study completionAug 2014

Resources

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
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02245854
Sponsor's protocol ID
E-Scope
Status last verified
Sep 2014
First submitted
1 Sep 2014
Last updated
22 Sep 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Repici A, Hassan C, Vitetta E, Ferrara E, Manes G, Gullotti G, Princiotta A, Dulbecco P, Gaffuri N, Bettoni E, Pagano N, Rando G, Strangio G, Carlino A, Romeo F, de Paula Pessoa Ferreira D, Zullo A, Ridola L, Malesci A. Safety of cold polypectomy for <10mm polyps at colonoscopy: a prospective multicenter study. Endoscopy. 2012 Jan;44(1):27-31. doi: 10.1055/s-0031-1291387. Epub 2011 Nov 28.

    PubMed 22125197

  • Ichise Y, Horiuchi A, Nakayama Y, Tanaka N. Prospective randomized comparison of cold snare polypectomy and conventional polypectomy for small colorectal polyps. Digestion. 2011;84(1):78-81. doi: 10.1159/000323959. Epub 2011 Apr 14.

    PubMed 21494037

  • Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N, Sano K, Graham DY. Removal of small colorectal polyps in anticoagulated patients: a prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc. 2014 Mar;79(3):417-23. doi: 10.1016/j.gie.2013.08.040. Epub 2013 Oct 11.

    PubMed 24125514

  • Paspatis GA, Tribonias G, Konstantinidis K, Theodoropoulou A, Vardas E, Voudoukis E, Manolaraki MM, Chainaki I, Chlouverakis G. A prospective randomized comparison of cold vs hot snare polypectomy in the occurrence of postpolypectomy bleeding in small colonic polyps. Colorectal Dis. 2011 Oct;13(10):e345-8. doi: 10.1111/j.1463-1318.2011.02696.x.

    PubMed 21689363

  • Lieberman D, Moravec M, Holub J, Michaels L, Eisen G. Polyp size and advanced histology in patients undergoing colonoscopy screening: implications for CT colonography. Gastroenterology. 2008 Oct;135(4):1100-5. doi: 10.1053/j.gastro.2008.06.083. Epub 2008 Jul 3.

    PubMed 18691580

  • Heldwein W, Dollhopf M, Rosch T, Meining A, Schmidtsdorff G, Hasford J, Hermanek P, Burlefinger R, Birkner B, Schmitt W; Munich Gastroenterology Group. The Munich Polypectomy Study (MUPS): prospective analysis of complications and risk factors in 4000 colonic snare polypectomies. Endoscopy. 2005 Nov;37(11):1116-22. doi: 10.1055/s-2005-870512.

    PubMed 16281142

  • Panteris V, Haringsma J, Kuipers EJ. Colonoscopy perforation rate, mechanisms and outcome: from diagnostic to therapeutic colonoscopy. Endoscopy. 2009 Nov;41(11):941-51. doi: 10.1055/s-0029-1215179. Epub 2009 Oct 28.

    PubMed 19866393

  • Atkin WS, Edwards R, Kralj-Hans I, Wooldrage K, Hart AR, Northover JM, Parkin DM, Wardle J, Duffy SW, Cuzick J; UK Flexible Sigmoidoscopy Trial Investigators. Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial. Lancet. 2010 May 8;375(9726):1624-33. doi: 10.1016/S0140-6736(10)60551-X. Epub 2010 Apr 27.

    PubMed 20430429

Questions about this trial

What is this clinical trial studying?

A study testing Exacto™ in people with Polyp of Large Intestine and Colonic Polyps, run by Istituto Clinico Humanitas at 3 sites in Italy.

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 3 inclusion and 9 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 22 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. 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?

Percentage of complete polyp removal (time frame: One 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 NCT02245854, which also lists 8 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 22 Sep 2014.

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