Ulcerative ColitisVCC2-RCHNCT02610569
Comparison of PillCamCOLON (C2) Capsule and Standard Endoscopy for the Evaluation of Patients With Ulcerative Colitis
A study testing standard endoscopy and PillCamCOLON (C2) in people with Ulcerative Colitis, run by Dr. Arnaud Bourreille at 1 site in France.
Trial summary
Ulcerative colitis (UC) is an inflammatory bowel disease progressing through flare-ups. The therapeutic objective, which was originally based on clinical remission, is currently evolving with the development of biotherapies towards the achievement of endoscopic remission. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- standard endoscopy and PillCamCOLON (C2)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Sep 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient between 18 and 70 years old
- Patient with UC requiring treatment with anti-TNFalpha or vedolizumab
- Patient affiliated to a social security scheme
- Patient able to understand and follow the study instructions
- Patient having signed an informed consent form
Who cannot join
- Patient with severe and acute colitis
- Patient with Crohn's disease or non-classified colitis
- Patient with an indication for surgical management of UC
- Patient with a history of sub-total or total colectomy, or with colostomy or ileostomy.
- Patient with a history of intestinal irradiation
- Patient with a known or suspected intestinal stricture
Show all 15Show fewer
- Patient with clinical signs suggestive of intestinal stricture
- Patient with dysphagia with choking on solid food or swallowing disorders
- Patient with a contra-indication for an anti TNFalpha treatment
- Patient with a contra-indication for conventional endoscopy (colonoscopy or recto-sigmoidoscopy)
- Patient with congestive heart failure or severe renal impairment
- Patient with a pacemaker or other implanted electronic medical device
- Patient participating in another interventional clinical trial
- Pregnant or nursing woman
- Vulnerable individuals: persons deprived of liberty, under tutelage or guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the PillCamCOLON (C2) Capsule With Standard Endoscopy for the Evaluation of the Severity and the Endoscopic Healing of Patients With Ulcerative Colitis (UC)
Ulcerative colitis (UC) is an inflammatory bowel disease progressing through flare-ups. The therapeutic objective, which was originally based on clinical remission, is currently evolving with the development of biotherapies towards the achievement of endoscopic remission. Current recommendations for therapeutic management advocate the achievement of endoscopic mucosal healing (EMH), with an observed decrease in the necessity for colectomy in the case of EMH. Endoscopic evaluation of the severity of UC is performed during a digestive endoscopy (colonoscopy for a complete colonic exploration, or recto-sigmoidoscopy for a partial exploration of the colon) from endoscopic activity scores adapted for UC.
Currently, the score the most commonly used is the MAYO endoscopic score. This is a global score of increasing intensity from 0 to 3, taking into account the following basic lesions: vascular pattern, granularity or/and friability of the mucosa, spontaneous bleeding, erosion and ulceration. However this score has limits: it does not distinguish deep cavitating ulcerations with mucous detachment from simple ulcerations which have a better prognosis.
Read more
A new endoscopic score specific for UC has been developed and is currently being validated. It is termed Ulcerative Colitis Endoscopic Index of Severity (UCEIS). This evaluation takes into account the three most reproducible factors - the vascular pattern, the presence of bleeding, and erosions or ulcerations including cavitating ulceration - in the total score.
To ensure optimal patient care and an adaptation of the therapeutic medical care to the endoscopic severity of the disease, endoscopic exploration should be performed recurrently. However, this exploration is an invasive procedure, requires general anaesthesia for colonoscopy, and can lead to potential complications such as perforation. This explains the poor acceptance by patients, resulting in a sub-optimal therapeutic support.
Read the detailed description
For each patient, the study will be conducted in accordance with the following schedule:
Information/inclusion visit: D-30 (± 30 days)
- Full information about the trial
- Verification of inclusion and non-inclusion criteria
- Acquisition of informed consent (either the same day or after a period of reflexion)
- Medical and surgical history
- Clinical examination
Endoscopic visit: D0 On two consecutive days or within a maximum of seven days but obligatorily before the anti-Tumor Necrosis Factor (TNF) alpha treatment
- Faecal sample (calprotectin)
- Clinical examination
- Endoscopic examination by PillCamCOLON (C2) then by conventional endoscopy (colonoscopy) -The endoscopic examinations will each be analyzed by a different endoscopist working in a blinded evaluation. An UC activity score will be calculated depending on two scores: MAYO and UCEIS.
- Notification of Adverse Event (AE) / Serious Adverse Event (SAE)
Follow-up visit: W12 (12 weeks ± 5 days after D0)
- Faecal sample (calprotectin)
- Clinical examination
- Endoscopic examination by PillCamCOLON (C2) then by conventional endoscopy (coloscopy) -The endoscopic examinations will each be analyzed by a different endoscopist working in a blinded evaluation. An UC activity score will be evaluated depending on two scores: MAYO and UCEIS.
- Notification of AE/SAE
End-of-study visit (possibly by telephone) W14 (± 5 days)
*Notification of AE/SAE
- Conditions
- Ulcerative Colitis
- Being tested
- standard endoscopy, PillCamCOLON (C2)
- Keywords
- Colonic capsule, ulcerative colitis, mucosal healing, endoscopic score
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard endoscopyDevice
standard endoscopy will be either colonoscopy or rectosigmoidoscopy
PillCamCOLON (C2)Device
PillCamCOLON (C2) is a colon video-capsule
| Study group | Role | What they receive |
|---|---|---|
| standart endoscopy | Active comparator | Intervention: 2 standard endoscopy during anti-TNFalpha or vedolizumab treatment Receives: Device: standard endoscopy |
| PillCamCOLON (C2) | Experimental | Intervention : 2 PillCamCOLON (C2) during anti-TNFalpha or vedolizumab treatment Receives: Device: PillCamCOLON (C2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between PillCamCOLON (C2) and conventional endoscopy for evaluation of the endoscopic MAYO score in patients with UC.
MAYO endoscopic score established by PillCamCOLON (C2) and conventional endoscopy of the common recto-colonic segment explored at week 12 (W12).
Measured: week 12 (W12)
Secondary outcomes (12)
Concordance between PillCamCOLON (C2) and conventional endoscopy for evaluation of the UCEIS score in patients with UC.
UCEIS endoscopic score established by PillCamCOLON (C2) and conventional endoscopy of the common recto-colonic segment explored at D0 and W12.
Measured: Week 12
Concordance between PillCamCOLON (C2) and conventional endoscopy for measuring the variation of Mayo scores during an anti-TNF alpha or vedolizumab treatment
Mayo endoscopic scores established by PillCamCOLON (C2) and conventional endoscopy of the common recto-colic segment explored at D0 versus W12
Measured: Week 12
Concordance between PillCamCOLON (C2) and conventional endoscopy for measuring the variation of the UCEIS scores during an anti-TNF alpha or vedolizumab treatment
UCEIS endoscopic scores established by PillCamCOLON (C2) and conventional endoscopy of the common recto-colic segment explored at W12
Measured: Week 12
Presence of lesions upstream of the left colonic flexure using PillCamCOLON (C2), when recto-sigmoidoscopy is the conventional endoscopic procedure used.
Description of lesions located upstream of the left colonic flexure in terms of their localization and severity (in particular, ulcerations) visualized by PillCamCOLON (C2) when recto-sigmoidoscopy is the conventional endoscopic procedure used (at W12).
Measured: Week 12
Capacity of PillCamCOLON (C2) to define endoscopic mucosal healing (MAYO score 0 and 1) as compared with recto-sigmoidoscopy, during treatment with anti-TNFalpha or vedolizumab.
Measured: Week 12
Correlation between calprotectin level in fecal sample and disease activity.
Calprotectin levels in fetal sample
Measured: Week 12
Level of adequate colonic preparation during examinations with PillCamCOLON (C2).
Measurement of the quality of colonic preparation, relative to the commonly used scale, using all PillCamCOLON (C2) films obtained.
Measured: Week 12
Reproducibility inter and intraobserver for the lesions' detection and for the severity grading by PillCamCOLON (C2)
Reproducibility inter and intraobserver concerning the lesions descriptions and their severity.
Measured: Week 12
Analog visual scale (AVS) the preference of the patients and their acceptability of each of 2 examinations
AVS on exams acceptability between PillCamCOLON (C2) and conventional endoscopy
Measured: Week 12
Adverse events due to PillCamCOLON (C2) and conventional endoscopy
To evaluate the tolerance of these two endoscopic examination procedures. Adverse events due to PillCamCOLON (C2) and adverse events due to conventional endoscopy.
Measured: Week 14
Capacity of PillCamCOLON (C2) to define the extent of UC, as compared with colonoscopy
Measured: Week 12
Percentage of complete exploration by PillCamCOLON (C2)
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startApr 2014
- Primary completionSep 2017
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Arnaud Bourreille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Arnaud Bourreille, Société Française d'Endoscopie Digestive
- Investigators
- Arnaud Bourreille, MD, Principal investigator, University Hospital of Nantes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610569
- Sponsor's protocol ID
- 2013-A01674-41
- Acronym
- VCC2-RCH
- Status last verified
- Nov 2024
- First submitted
- 27 Apr 2015
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the PillCamCOLON (C2) Capsule With Standard Endoscopy for the Evaluation of the Severity and the Endoscopic Healing of Patients With Ulcerative Colitis (UC)
- ClinicalTrials.gov ID
- NCT02610569
- Acronym / sponsor ID
- VCC2-RCH / 2013-A01674-41
- Conditions
- Ulcerative Colitis
- Keywords
- Colonic capsule, ulcerative colitis, mucosal healing, endoscopic score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dr. Arnaud BourreilleUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 20 Nov 2015 (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.
Ulcerative colitis (UC) is an inflammatory bowel disease progressing through flare-ups. The therapeutic objective, which was originally based on clinical remission, is currently evolving with the development of biotherapies towards the achievement of endoscopic remission. Current recommendations for therapeutic management advocate the achievement of endoscopic mucosal healing (EMH), with an observed decrease in the necessity for colectomy in the case of EMH. Endoscopic evaluation of the severity of UC is performed during a digestive endoscopy (colonoscopy for a complete colonic exploration, or recto-sigmoidoscopy for a partial exploration of the colon) from endoscopic activity scores adapted for UC.
Currently, the score the most commonly used is the MAYO endoscopic score. This is a global score of increasing intensity from 0 to 3, taking into account the following basic lesions: vascular pattern, granularity or/and friability of the mucosa, spontaneous bleeding, erosion and ulceration. However this score has limits: it does not distinguish deep cavitating ulcerations with mucous detachment from simple ulcerations which have a better prognosis.
A new endoscopic score specific for UC has been developed and is currently being validated. It is termed Ulcerative Colitis Endoscopic Index of Severity (UCEIS). This evaluation takes into account the three most reproducible factors - the vascular pattern, the presence of bleeding, and erosions or ulcerations including cavitating ulceration - in the total score.
To ensure optimal patient care and an adaptation of the therapeutic medical care to the endoscopic severity of the disease, endoscopic exploration should be performed recurrently. However, this exploration is an invasive procedure, requires general anaesthesia for colonoscopy, and can lead to potential complications such as perforation. This explains the poor acceptance by patients, resulting in a sub-optimal therapeutic support.
Detailed description
For each patient, the study will be conducted in accordance with the following schedule:
Information/inclusion visit: D-30 (± 30 days)
- Full information about the trial
- Verification of inclusion and non-inclusion criteria
- Acquisition of informed consent (either the same day or after a period of reflexion)
- Medical and surgical history
- Clinical examination
Endoscopic visit: D0 On two consecutive days or within a maximum of seven days but obligatorily before the anti-Tumor Necrosis Factor (TNF) alpha treatment
- Faecal sample (calprotectin)
- Clinical examination
- Endoscopic examination by PillCamCOLON (C2) then by conventional endoscopy (colonoscopy) -The endoscopic examinations will each be analyzed by a different endoscopist working in a blinded evaluation. An UC activity score will be calculated depending on two scores: MAYO and UCEIS.
- Notification of Adverse Event (AE) / Serious Adverse Event (SAE)
Follow-up visit: W12 (12 weeks ± 5 days after D0)
- Faecal sample (calprotectin)
- Clinical examination
- Endoscopic examination by PillCamCOLON (C2) then by conventional endoscopy (coloscopy) -The endoscopic examinations will each be analyzed by a different endoscopist working in a blinded evaluation. An UC activity score will be evaluated depending on two scores: MAYO and UCEIS.
- Notification of AE/SAE
End-of-study visit (possibly by telephone) W14 (± 5 days)
*Notification of AE/SAE
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standart endoscopy | Active comparator | Device: standard endoscopyIntervention: 2 standard endoscopy during anti-TNFalpha or vedolizumab treatment |
| PillCamCOLON (C2) | Experimental | Device: PillCamCOLON (C2)Intervention : 2 PillCamCOLON (C2) during anti-TNFalpha or vedolizumab treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patient between 18 and 70 years old
- Patient with UC requiring treatment with anti-TNFalpha or vedolizumab
- Patient affiliated to a social security scheme
- Patient able to understand and follow the study instructions
- Patient having signed an informed consent form
Key exclusion criteria (15 listed)
- Patient with severe and acute colitis
- Patient with Crohn's disease or non-classified colitis
- Patient with an indication for surgical management of UC
- Patient with a history of sub-total or total colectomy, or with colostomy or ileostomy.
- Patient with a history of intestinal irradiation
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 |
|---|---|---|
| standard endoscopystandard endoscopy will be either colonoscopy or rectosigmoidoscopy | Device | standart endoscopy |
| PillCamCOLON (C2)PillCamCOLON (C2) is a colon video-capsule | Device | PillCamCOLON (C2) |
Primary outcome
Concordance between PillCamCOLON (C2) and conventional endoscopy for evaluation of the endoscopic MAYO score in patients with UC.
Time frame: week 12 (W12)
MAYO endoscopic score established by PillCamCOLON (C2) and conventional endoscopy of the common recto-colonic segment explored at week 12 (W12).
12 secondary outcomes
Concordance between PillCamCOLON (C2) and conventional endoscopy for evaluation of the UCEIS score in patients with UC.
Time frame: Week 12
Concordance between PillCamCOLON (C2) and conventional endoscopy for measuring the variation of Mayo scores during an anti-TNF alpha or vedolizumab treatment
Time frame: Week 12
Concordance between PillCamCOLON (C2) and conventional endoscopy for measuring the variation of the UCEIS scores during an anti-TNF alpha or vedolizumab treatment
Time frame: Week 12
Presence of lesions upstream of the left colonic flexure using PillCamCOLON (C2), when recto-sigmoidoscopy is the conventional endoscopic procedure used.
Time frame: Week 12
Capacity of PillCamCOLON (C2) to define endoscopic mucosal healing (MAYO score 0 and 1) as compared with recto-sigmoidoscopy, during treatment with anti-TNFalpha or vedolizumab.
Time frame: Week 12
Correlation between calprotectin level in fecal sample and disease activity.
Time frame: Week 12
Level of adequate colonic preparation during examinations with PillCamCOLON (C2).
Time frame: Week 12
Reproducibility inter and intraobserver for the lesions' detection and for the severity grading by PillCamCOLON (C2)
Time frame: Week 12
Analog visual scale (AVS) the preference of the patients and their acceptability of each of 2 examinations
Time frame: Week 12
Adverse events due to PillCamCOLON (C2) and conventional endoscopy
Time frame: Week 14
Capacity of PillCamCOLON (C2) to define the extent of UC, as compared with colonoscopy
Time frame: Week 12
Percentage of complete exploration by PillCamCOLON (C2)
Time frame: Week 12
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 29 Nov 2024.
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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.
Arnaud Bourreille, MD principal investigator
University Hospital of Nantes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard endoscopy and PillCamCOLON (C2) in people with Ulcerative Colitis, run by Dr. Arnaud Bourreille at 1 site in France.
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 15 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 29 Nov 2024. 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 France. 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?
Concordance between PillCamCOLON (C2) and conventional endoscopy for evaluation of the endoscopic MAYO score in patients with UC. (time frame: week 12 (W12)). 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 29 Nov 2024.