Colon CancerNCT01868971
Clinical Study to Establish the Feasibility and Usability of the EndoRings™
A study testing EndoRings in people with Colon Cancer and Bowel Cancer, run by EndoAid at 1 site in Israel.
Trial summary
The purpose of this prospective clinical study is to establish the feasibility and usability of the ENDORINGS™ when used during standard colonoscopy procedure. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Bowel Cancer, Colorectal Cancer
- What is being tested?
- EndoRings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2013to Oct 2013
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any subject who meets all of the following criteria may be included in this study:
- Subject between the ages of 18 and 70
- The patient is undergoing colonoscopy for screening, or for surveillance in follow-up of previous polypectomy or for diagnostic workup;
- Written informed consent must be available before enrollment in the trial
- For women with childbearing potential, adequate contraception
Who cannot join
- Any subject who meets any of the following criteria will not be included in this study:
- Patients with a history of colonic resection;
- Patients with inflammatory bowel disease;
- 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;
- 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
1 site in 1 country.
About this study
Official title: EndoRings™ - Clinical Protocol
The purpose of this prospective clinical study is to establish the feasibility and usability of the ENDORINGS™ when used during standard colonoscopy procedure.
Read the detailed description
The EndoAid Ltd. EndoRings is used during endoscopy procedures. The EndoRings is a short silicon rubber tube with flexible circular wings that attaches to the distal end of the endoscope to facilitate endoscopic therapy.
The EndoRings is designed to fit specific endoscopes (as designated on the packaging), and is supplied sterile following ETO sterilization and is single use only.
Indications for Use:
To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:
- Keeping the suitable depth of endoscope's view field
- Helping the endoscope with being inserted into the gastrointestinal tract
Patient Population: The study population is comprised of patients indicated for colonoscopy.
Study Design: Single-center study. A single treatment group of 60 patients. No. of Patients: Up to sixty (60) treated patients will be enrolled in the study.
Primary Endpoints:The primary endpoint is reaching the cecum of the colon with the ENDORINGS™.
Secondary Endpoints / Other Outcomes:
- Incidence of complications (number of complications)
- Ability to complete s therapeutic interventions as biopsies, polypectomies, APC etc.
- Procedure time.
- Ease of scope insertion, advancement and withdrawal.
- Ability to center the scope inside the gastrointestinal tract.
- Subjective evaluation of the additional area screened by the physician (recorded in the source documents by a questionnaire).
- Patient satisfactory (by a follow up phone-call in which questionnaire with VAS scale will be filled out).
- Conditions
- Colon Cancer, Bowel Cancer, Colorectal Cancer
- Being tested
- EndoRings
- Keywords
- EndoRings
- Medical subject headings
- Colonic Neoplasms, Intestinal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoRingsDevice
Colonoscopy procedure, standard endo-therapy interventions will be performed in accordance with physician's evaluation
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy procedure with the EndoRings | Other | Colonoscopy procedure using an add-on device (EndoRings) that is attached to the distal tip of the endoscope Receives: Device: EndoRings |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is reaching the cecum of the colon with the ENDORINGS™.
Measured: 24 hours post procedure
Secondary outcomes (7)
1. Incidence of complications (number of complications)
Known complications include:
- Perforation;
- Severe abdominal pain;
- Infection;
- Bleeding (other than expected minor bleeding due to therapeutic procedures e.g. polypectomy);
- Inducing inflammation of diverticulum
- Arrhythmia, bradycardia, hypotension, hypoxia
- Death A complication is defined as any one of the above complications as well as any other unexpected complication requiring medical intervention beyond that of the standard procedure. All adverse events will be reported and treated as per the standard clinical practices.
A telephone call should be made to the patient at 24 hour post- procedure, to assess post-examination adverse events.
Measured: 24 hours post procedure
2. Ability to complete s therapeutic interventions as biopsies, polypectomies, APC etc.
Whenever a polyp or other abnormality is detected, the endoscopist will perform biopsy, polypectomy or other evaluation or therapy as appropriate. The clinical investigator will use his/her clinical judgment on the safety of polyp removal/biopsy.
Measured: 24 hours post procedure
3. Procedure time.
Procedural times for each colonoscopy procedure:
- Time for intubation to the cecum
- Time for withdrawal from the cecum to the anal verge
- Total procedure time
Measured: During procedure
4. Ease of scope insertion, advancement and withdrawal.
Physician's subjective evaluation will be recorded in the source documents by a questionnaire.
Measured: During procedure
5. Ability to center the scope inside the gastrointestinal tract.
Physician's subjective evaluation will be recorded in the source documents by a questionnaire.
Measured: During procedure
6. Subjective evaluation of the additional area screened by the physician.
Physician's subjective evaluation will be recorded in the source documents by a questionnaire.
Measured: During procedure
7. Patient satisfactory.
A telephone call should be made to the patient at 24 hour post- procedure, to assess patient satisfactory by completing a VAS scale questionnaire.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- EndoAid
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ian Gralnek, Prof., Principal investigator, Attending Physician at Elisha Hospital, Haifa, Israel ~~~~~ Chief, Hospital-Wide Ambulatory Care Services Head, GI Outcomes Unit and Senior Physician Department of Gastroenterology Rambam Health Care Campus Rappaport Faculty of Medicine, Technion-Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868971
- Sponsor's protocol ID
- CSDPR100
- Status last verified
- Jul 2017
- First submitted
- 29 May 2013
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EndoRings™ - Clinical Protocol
- ClinicalTrials.gov ID
- NCT01868971
- Acronym / sponsor ID
- CSDPR100
- Conditions
- Colon Cancer, Bowel Cancer, Colorectal Cancer
- Keywords
- EndoRings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- EndoAidIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 5 Jun 2013 (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 purpose of this prospective clinical study is to establish the feasibility and usability of the ENDORINGS™ when used during standard colonoscopy procedure.
Detailed description
The EndoAid Ltd. EndoRings is used during endoscopy procedures. The EndoRings is a short silicon rubber tube with flexible circular wings that attaches to the distal end of the endoscope to facilitate endoscopic therapy.
The EndoRings is designed to fit specific endoscopes (as designated on the packaging), and is supplied sterile following ETO sterilization and is single use only.
Indications for Use:
To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:
- Keeping the suitable depth of endoscope's view field
- Helping the endoscope with being inserted into the gastrointestinal tract
Patient Population: The study population is comprised of patients indicated for colonoscopy.
Study Design: Single-center study. A single treatment group of 60 patients. No. of Patients: Up to sixty (60) treated patients will be enrolled in the study.
Primary Endpoints:The primary endpoint is reaching the cecum of the colon with the ENDORINGS™.
Secondary Endpoints / Other Outcomes:
- Incidence of complications (number of complications)
- Ability to complete s therapeutic interventions as biopsies, polypectomies, APC etc.
- Procedure time.
- Ease of scope insertion, advancement and withdrawal.
- Ability to center the scope inside the gastrointestinal tract.
- Subjective evaluation of the additional area screened by the physician (recorded in the source documents by a questionnaire).
- Patient satisfactory (by a follow up phone-call in which questionnaire with VAS scale will be filled out).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy procedure with the EndoRings | Other | Device: EndoRingsColonoscopy procedure using an add-on device (EndoRings) that is attached to the distal tip of the endoscope |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject between the ages of 18 and 70
- The patient is undergoing colonoscopy for screening, or for surveillance in follow-up of previous polypectomy or for diagnostic workup;
- Written informed consent must be available before enrollment in the trial
- For women with childbearing potential, adequate contraception
Key exclusion criteria (8 listed)
- Patients with a history of colonic resection;
- Patients with inflammatory bowel disease;
- Patients with a personal history of polyposis syndrome;
- Patients with suspected chronic stricture potentially precluding complete colonoscopy;
- Patients with diverticulitis or toxic megacolon;
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 |
|---|---|---|
| EndoRingsColonoscopy procedure, standard endo-therapy interventions will be performed in accordance with physician's evaluation | Device | Colonoscopy procedure with the EndoRings |
Primary outcome
The primary endpoint is reaching the cecum of the colon with the ENDORINGS™.
Time frame: 24 hours post procedure
7 secondary outcomes
1. Incidence of complications (number of complications)
Time frame: 24 hours post procedure
2. Ability to complete s therapeutic interventions as biopsies, polypectomies, APC etc.
Time frame: 24 hours post procedure
3. Procedure time.
Time frame: During procedure
4. Ease of scope insertion, advancement and withdrawal.
Time frame: During procedure
5. Ability to center the scope inside the gastrointestinal tract.
Time frame: During procedure
6. Subjective evaluation of the additional area screened by the physician.
Time frame: During procedure
7. Patient satisfactory.
Time frame: During procedure
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 28 Jul 2017.
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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.
Ian Gralnek, Prof. principal investigator
Attending Physician at Elisha Hospital, Haifa, Israel ~~~~~ Chief, Hospital-Wide Ambulatory Care Services Head, GI Outcomes Unit and Senior Physician Department of Gastroenterology Rambam Health Care Campus Rappaport Faculty of Medicine, Technion-Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoRings in people with Colon Cancer and Bowel Cancer, run by EndoAid at 1 site in Israel.
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 28 Jul 2017. 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 Israel. 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?
The primary endpoint is reaching the cecum of the colon with the ENDORINGS™. (time frame: 24 hours post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2017.