ColonoscopyNCT01115010
Effectiveness of Stiffening Wire in Colonoscopy With Pre-Owned Colonoscopes
A study testing Colonoscope stiffening device in people with Colonoscopy, run by Cornwall Regional Hospital at 1 site in Jamaica.
Trial summary
The study aims to determine whether a proprietary, FDA approved stiffening wire improves the efficiency of colonoscopy (that is, decreases the duration of the procedure) and/or enables complete visualization of the colon in a greater proportion of cases (than when the procedure is performed without it) with old, used… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Colonoscope stiffening device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteJamaica
- Study dates
- Dec 2009to Jan 2011
- 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
- Adults 18 years and older having screening or diagnostic colonoscopy
Who cannot join
- Previous hysterectomy
- Previous radical prostatectomy
- Clinical presentation or imaging study suggesting presence of lesion that could obstruct passage of colonoscope
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Proprietary Intraluminal Stiffening Wire in Decreasing Procedure Time and Improving Cecal Intubation Rate With Pre-owned Colonoscopes; a Randomized, Controlled Trial
The study aims to determine whether a proprietary, FDA approved stiffening wire improves the efficiency of colonoscopy (that is, decreases the duration of the procedure) and/or enables complete visualization of the colon in a greater proportion of cases (than when the procedure is performed without it) with old, used colonoscopes.
Colonoscopes are designed with a delicate balance between stiffness and flexibility. Stiffness helps to prevent curling (looping) of the colonoscope in those sections of the colon that are not fixed to the wall of the abdominal cavity and flexibility enables successful negotiation of bends or flexures in the colon. As colonoscopes age, they lose stiffness and this makes it very challenging to advance the colonoscope all the way to the cecum (the upper end of the colon). Even when the cecum is successfully reached, it may take an inordinately long time.
Read more
In Jamaica, most endoscopists (General Surgeons and Gastroenterologists) use older, pre-owned colonoscopes imported from the USA, because the average patient and local health insurance companies cannot bear the level of fees that would enable cost recovery for new equipment.
The stiffening wires (in two grades of stiffness) used in this study are passed through the biopsy channel of the colonoscope only after its tip has passed the upper end of the descending colon and entered the transverse colon. The device is safe when used as recommended by the manufacturers (and approved by the FDA), and does not appear to increase risk over and above the risk of colonoscopy with the unassisted colonoscope. Although the device clearly improves the stiffness of the colonoscope, there is no research evidence that it actually works in practice, either to improve cecal intubation rate or to decrease procedure time. It is therefore also unclear whether the possible benefit of using the device is achieved if introduced at the first opportunity allowed by the manufacturers or only after difficulty is encountered with the unassisted colonoscope.
In this study, patients are randomly assigned to one of 3 "interventions". One group has colonoscopy performed with the colonoscope alone and the wires are only introduced if there is difficulty advancing the colonoscope after it has passed into the transverse colon ("difficulty" defined as failure to advance the tip of the colonoscope after 5 minutes). In the 2nd and 3rd groups, the assigned wire will be introduced as soon as the colonoscope enters the transverse colon and is removed if "difficulty" is encountered, as defined above. The different phases of colonoscopy will be timed with a stop watch and when a sufficient number of patients has been accrued, the investigator will be able to compare the time it takes to complete the procedure with and without the wires as well as the proportion of cases in which the cecum was reached with and without the assistance of the wires.
- Conditions
- Colonoscopy
- Being tested
- Colonoscope stiffening device
- Keywords
- intubation rate, intubation time, stiffening device, stiffening wire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscope stiffening deviceDevice
Also called ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical
Colonoscopy is performed with the unassisted colonoscope (Olympus CF-100TL). The "standard" stiffening wire is introduced only if there is difficulty advancing the colonoscope and only after the tip has passed the splenic flexure. Difficulty is defined as failure to advance the tip of the scope after 5 minutes of trying. If difficulty is again encountered, the "firm" wire replaces the "standard" wire. Further difficulty requires removal of the firm wire and so on until cecal intubation is achieved or the procedure is abandoned.
Colonoscope stiffening deviceDevice
Also called ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical
"Standard" stiffening wire introduced routinely on entry into transverse colon. If difficulty is encountered (as defined previously), the "standard" wire is removed and attempts made to advance the colonoscope without it. Further difficulty requires introduction of the "firm" wire and so on until cecal intubation is achieved or the procedure is abandoned.
Colonoscope stiffening deviceDevice
Also called ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical
"Firm" stiffening wire introduced routinely on entry into transverse colon. If difficulty is encountered (as defined previously), the wire is removed and attempts made to advance the colonoscope without it. Further difficulty requires introduction of the "standard" wire and so on until cecal intubation is achieved or the procedure is abandoned.
| Study group | Role | What they receive |
|---|---|---|
| Stiffening wire only if difficulty | Experimental | Colonoscopy is performed with the unassisted colonoscope. The stiffening wire is introduced only if there is difficulty advancing the colonoscope and only after the tip has passed the splenic flexure. Difficulty is defined as failure to advance the tip of the scope after 5 minutes of trying. Receives: Device: Colonoscope stiffening device |
| Stiffening wire #1 transverse colon | Experimental | Colonoscopy is started with the unassisted colonoscope. Stiffening wire #1 is introduced on entry of the tip of the colonoscope into the transverse colon. Receives: Device: Colonoscope stiffening device |
| Stiffening wire #2 transverse colon | Experimental | Colonoscopy is started with the unassisted colonoscope. Stiffening wire #2 is introduced on entry of the tip of the colonoscope into the transverse colon. Receives: Device: Colonoscope stiffening device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cecal intubation
Measured: 10 months
Secondary outcomes (1)
Time to cecal intubation
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startDec 2009
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: Colonoscope being used in study not repairable at economic cost.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornwall Regional Hospital
- Sponsor type
- Other government
- Collaborators
- MoBay Hope Medical Center, Jamaica
- Investigators
- Jeffrey M East, MD, Principal investigator, Cornwall Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115010
- Sponsor's protocol ID
- JE-1
- Status last verified
- Jul 2011
- First submitted
- 29 Apr 2010
- Last updated
- 3 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Odori T, Goto H, Arisawa T, Niwa Y, Ohmiya N, Hayakawa T. Clinical results and development of variable-stiffness video colonoscopes. Endoscopy. 2001 Jan;33(1):65-9. doi: 10.1055/s-2001-11174.
PubMed 11204990Shah SG, Saunders BP. Aids to insertion: magnetic imaging, variable stiffness, and overtubes. Gastrointest Endosc Clin N Am. 2005 Oct;15(4):673-86. doi: 10.1016/j.giec.2005.08.011.
PubMed 16278132Sivak MV. Gastroenterologic Endoscopy. Second Edition. W.B. Saunders, 1999.
Zutron Medical. Colonoscope stiffening device. http://zutronmedical.storesecured.com/items/Endoscope-Stiffening-System/list.htm . 2009. Ref Type: Electronic Citation
Smith PG, Morrow RH. Field Trials of Health Interventions in Developing Countries: A Toolbox. 2nd ed. London: Macmillan Education, 1996.
Othman MO, Bradley AG, Choudhary A, Hoffman RM, Roy PK. Variable stiffness colonoscope versus regular adult colonoscope: meta-analysis of randomized controlled trials. Endoscopy. 2009 Jan;41(1):17-24. doi: 10.1055/s-0028-1103488. Epub 2009 Jan 21.
PubMed 19160154Baron TH. The variable stiffness colonoscope: a scope for all seasons? Am J Gastroenterol. 2002 Dec;97(12):2942-3. doi: 10.1111/j.1572-0241.2002.07091.x. No abstract available.
PubMed 12492173East JM. Effect of a proprietary intraluminal stiffening wire device on cecal intubation time and rate with used colonoscopes; a randomized, controlled trial. BMC Res Notes. 2013 Feb 4;6:48. doi: 10.1186/1756-0500-6-48.
PubMed 23379922
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Proprietary Intraluminal Stiffening Wire in Decreasing Procedure Time and Improving Cecal Intubation Rate With Pre-owned Colonoscopes; a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01115010
- Acronym / sponsor ID
- JE-1
- Conditions
- Colonoscopy
- Keywords
- intubation rate, intubation time, stiffening device, stiffening wire
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Colonoscope being used in study not repairable at economic cost.
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Cornwall Regional HospitalOther government
- Collaborators
- MoBay Hope Medical Center, Jamaica
- Study start
- Dec 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 May 2010 (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 study aims to determine whether a proprietary, FDA approved stiffening wire improves the efficiency of colonoscopy (that is, decreases the duration of the procedure) and/or enables complete visualization of the colon in a greater proportion of cases (than when the procedure is performed without it) with old, used colonoscopes.
Colonoscopes are designed with a delicate balance between stiffness and flexibility. Stiffness helps to prevent curling (looping) of the colonoscope in those sections of the colon that are not fixed to the wall of the abdominal cavity and flexibility enables successful negotiation of bends or flexures in the colon. As colonoscopes age, they lose stiffness and this makes it very challenging to advance the colonoscope all the way to the cecum (the upper end of the colon). Even when the cecum is successfully reached, it may take an inordinately long time.
In Jamaica, most endoscopists (General Surgeons and Gastroenterologists) use older, pre-owned colonoscopes imported from the USA, because the average patient and local health insurance companies cannot bear the level of fees that would enable cost recovery for new equipment.
The stiffening wires (in two grades of stiffness) used in this study are passed through the biopsy channel of the colonoscope only after its tip has passed the upper end of the descending colon and entered the transverse colon. The device is safe when used as recommended by the manufacturers (and approved by the FDA), and does not appear to increase risk over and above the risk of colonoscopy with the unassisted colonoscope. Although the device clearly improves the stiffness of the colonoscope, there is no research evidence that it actually works in practice, either to improve cecal intubation rate or to decrease procedure time. It is therefore also unclear whether the possible benefit of using the device is achieved if introduced at the first opportunity allowed by the manufacturers or only after difficulty is encountered with the unassisted colonoscope.
In this study, patients are randomly assigned to one of 3 "interventions". One group has colonoscopy performed with the colonoscope alone and the wires are only introduced if there is difficulty advancing the colonoscope after it has passed into the transverse colon ("difficulty" defined as failure to advance the tip of the colonoscope after 5 minutes). In the 2nd and 3rd groups, the assigned wire will be introduced as soon as the colonoscope enters the transverse colon and is removed if "difficulty" is encountered, as defined above. The different phases of colonoscopy will be timed with a stop watch and when a sufficient number of patients has been accrued, the investigator will be able to compare the time it takes to complete the procedure with and without the wires as well as the proportion of cases in which the cecum was reached with and without the assistance of the wires.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stiffening wire only if difficulty | Experimental | Device: Colonoscope stiffening deviceColonoscopy is performed with the unassisted colonoscope. The stiffening wire is introduced only if there is difficulty advancing the colonoscope and only after the tip has passed the splenic flexure. Difficulty is defined as failure to advance the tip of the scope after 5 minutes of trying. |
| Stiffening wire #1 transverse colon | Experimental | Device: Colonoscope stiffening deviceColonoscopy is started with the unassisted colonoscope. Stiffening wire #1 is introduced on entry of the tip of the colonoscope into the transverse colon. |
| Stiffening wire #2 transverse colon | Experimental | Device: Colonoscope stiffening deviceColonoscopy is started with the unassisted colonoscope. Stiffening wire #2 is introduced on entry of the tip of the colonoscope into the transverse colon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults 18 years and older having screening or diagnostic colonoscopy
Key exclusion criteria (3 listed)
- Previous hysterectomy
- Previous radical prostatectomy
- Clinical presentation or imaging study suggesting presence of lesion that could obstruct passage of colonoscope
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 |
|---|---|---|
| Colonoscope stiffening deviceAlso: ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron MedicalColonoscopy is performed with the unassisted colonoscope (Olympus CF-100TL). The "standard" stiffening wire is introduced only if there is difficulty advancing the colonoscope and only after the tip has passed the splenic flexure. Difficulty is defined as failure to advance the tip of the scope after 5 minutes of trying. If difficulty is again encountered, the "firm" wire replaces the "standard" wire. Further difficulty requires removal of the firm wire and so on until cecal intubation is achieved or the procedure is abandoned. | Device | Stiffening wire only if difficulty |
| Colonoscope stiffening deviceAlso: ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical"Standard" stiffening wire introduced routinely on entry into transverse colon. If difficulty is encountered (as defined previously), the "standard" wire is removed and attempts made to advance the colonoscope without it. Further difficulty requires introduction of the "firm" wire and so on until cecal intubation is achieved or the procedure is abandoned. | Device | Stiffening wire #1 transverse colon |
| Colonoscope stiffening deviceAlso: ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical"Firm" stiffening wire introduced routinely on entry into transverse colon. If difficulty is encountered (as defined previously), the wire is removed and attempts made to advance the colonoscope without it. Further difficulty requires introduction of the "standard" wire and so on until cecal intubation is achieved or the procedure is abandoned. | Device | Stiffening wire #2 transverse colon |
Primary outcome
Cecal intubation
Time frame: 10 months
1 secondary outcome
Time to cecal intubation
Time frame: 10 months
Results and safety
The study was stopped early (reason given: Colonoscope being used in study not repairable at economic cost.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2011.
- Background: PubMed 11204990Odori T, Goto H, Arisawa T, Niwa Y, Ohmiya N, Hayakawa T. Clinical results and development of variable-stiffness video colonoscopes. Endoscopy. 2001 Jan;33(1):65-9. doi: 10.1055/s-2001-11174.
- Background: PubMed 16278132Shah SG, Saunders BP. Aids to insertion: magnetic imaging, variable stiffness, and overtubes. Gastrointest Endosc Clin N Am. 2005 Oct;15(4):673-86. doi: 10.1016/j.giec.2005.08.011.
- BackgroundSivak MV. Gastroenterologic Endoscopy. Second Edition. W.B. Saunders, 1999.
- BackgroundZutron Medical. Colonoscope stiffening device. http://zutronmedical.storesecured.com/items/Endoscope-Stiffening-System/list.htm . 2009. Ref Type: Electronic Citation
- BackgroundSmith PG, Morrow RH. Field Trials of Health Interventions in Developing Countries: A Toolbox. 2nd ed. London: Macmillan Education, 1996.
- Background: PubMed 19160154Othman MO, Bradley AG, Choudhary A, Hoffman RM, Roy PK. Variable stiffness colonoscope versus regular adult colonoscope: meta-analysis of randomized controlled trials. Endoscopy. 2009 Jan;41(1):17-24. doi: 10.1055/s-0028-1103488. Epub 2009 Jan 21.
- Background: PubMed 12492173Baron TH. The variable stiffness colonoscope: a scope for all seasons? Am J Gastroenterol. 2002 Dec;97(12):2942-3. doi: 10.1111/j.1572-0241.2002.07091.x. No abstract available.
- Derived from this study: PubMed 23379922East JM. Effect of a proprietary intraluminal stiffening wire device on cecal intubation time and rate with used colonoscopes; a randomized, controlled trial. BMC Res Notes. 2013 Feb 4;6:48. doi: 10.1186/1756-0500-6-48.
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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.
Jeffrey M East, MD principal investigator
Cornwall Regional Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscope stiffening device in people with Colonoscopy, run by Cornwall Regional Hospital at 1 site in Jamaica.
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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 3 Aug 2011. 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 Jamaica. 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 was stopped early (reason given: Colonoscope being used in study not repairable at economic cost.). Results are not available in the source record.
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?
Cecal intubation (time frame: 10 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 NCT01115010, 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 3 Aug 2011.