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Status unknownNCT06515171Updated Jul 25, 2024

Efficacy and Safety of Bowel Preparation for Patency Capsule in CD Patients Who Previously Failed Patency Capsule

An observational study in Crohn Disease and Crohn Disease of Small Intestine, sponsored by Shmuel Kivity, MD. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-25.

Sponsored by Shmuel Kivity, MD · Observational

The sponsor has not verified this record recently (last verified Jul 2024), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
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Study summary

The goal of this observational study is to evaluate the success rate of a second bowel preparation protocol for patency capsule (PC) in Crohn Disease (CD) patients who failed to pass an initial protocol PC on a previous attempt.

The main question it aims to answer is what is the percentage of patients successfully passing the second PC test, among those who failed the first attempt.

Participants who will fail the PC test will be scheduled for another test with a different preparation protocol.

Participants will be asked to report capsule expulsion and send a photo for documentation or report the result of the abdominal X-ray preformed 28-30 hours post swallowing.

.

Read the detailed description

Crohn's disease (CD) involves the entire length of the gastrointestinal tract, including a large proportion of patients with small bowel involvement. Most of the small bowel length is not accessible by conventional endoscopy for diagnosis and routine follow-up. During their lifetime these patients require repeated evaluation of disease activity and extent. Traditionally this evaluation is achieved by periodic CT or MR enterography that involves repeated exposure to radiation and contrast materials and does not provide good mucosal assessment. The use of video capsule endoscopy (VCE) among CD patients provides a good mucosal assessment without exposure to radiation or contrast material, or the risks of conventional endoscopy and sedation.

The caveat of VCE in CD is the concern of capsule retention due to strictures which are sometimes asymptomatic. This is more pronounced in patients with clinical or radiographic features implying small bowel obstruction: stricturing /fistulizing disease phenotype, abdominal pain and bloating after meals, improvement with liquid diet, stenosis and proximal dilatation on imaging studies. In these high-risk patients a patency capsule (PC) test is recommended prior to VCE. The PC is a capsule in similar dimensions to that of the VCE which contains radio-opaque components and a cellophane coat that dissolves after approximately 30 hours. Patients failing to pass the pill after 30 hours continue assessment with plain abdominal X-ray imaging or a dedicated scanner in order to confirm or deny PC expulsion. If the test is positive and the PC was not expelled, the recommendation is to avoid VCE use and limit the patient to periodical imaging and conventional endoscopy as mentioned earlier. The probability for a positive PC test is 20-30% in high risk CD patients and thus, paradoxically, some of the patients who may benefit the most from VCE, will not undergo it. Nevertheless, VCE retention rate is estimated to occur in \~ 2% of patients. However, both PC and VCE are considered safe procedures and complications even in case of capsule retention are rare.

Given that the normal transit time of the entire digestive tract is up to 72 hours, delayed expulsion of the PC (i.e. >30 hours) can simply be due to slow transit or large amount of content in the large bowel and not a small bowel obstruction. Currently there are no guidelines regarding PC preparation protocol, but It seems slow transit can probably be overcome by bowel preparation.

In the endoscopic capsule unit of the TLVMC, we implement routinely a second attempt for bowel preparation, in CD patients who fail their first attempt to pass the capsule. Studies evaluating the safety and efficacy of this protocol is lacking.

02

Conditions studied

  • Crohn Disease
  • Crohn Disease of Small Intestine

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03

In context

Crohn Disease

1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.

This study's planned enrollment of 400 is above the median of 166 across 624 observational studies indexed under Crohn Disease.

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Lead sponsor

Shmuel Kivity, MD is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

CD patients referred for PC before VCE

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Crohn Disease patients intendent to perform Capsule endoscopy .

Exclusion criteria

Exclusion Criteria:

  • Severe obstructive symptoms according to physician discretion
  • Pregnancy
  • Inability to sign informed consent
  • Inability to complete the VCE procedure
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • CD patients referred for PC before VCE

    No intervention will be administered. Endoscopic capsule protocol will be performed in a uniform manner on all participants in the study as part of their routine clinical evaluation regardless of the study. The patient will report capsule expulsion and send a photo for documentation or report the result of the abdominal X-ray preformed 28-30 hours post swallowing

  • CD patients who failed to pass an initial protocol PC on a previous attempt.

    All the patients who failed the PC test will be scheduled for another test with a different preparation protocol, a common practice also today. This will be done as a standard procedure, in the clinical setting of the endoscopic capsule clinic and not as part of the study. Again, the patient will report capsule expulsion and send a photo for documentation or report the result of the abdominal X-ray preformed 28-30 hours post swallowing. If the second test was positive as well, an abdominal x-ray will be performed within 2 weeks to rule out PC retention - standard protocol for PC retention.

06

What researchers measure

Primary outcomes

  1. Rate of second PC passaging

    The percentage of patients successfully passing the second PC test, among those who fail the first attempt.

    Time frame: 3 years

Secondary outcomes

  1. PC retention

    The rate of PC retention

    Time frame: 3 years

  2. VCE retention

    The rate of VCE retention

    Time frame: 3 years

  3. Positive PC passage

    The rate of positive PC in CD patients

    Time frame: 3 years

  4. Risk factors

    Risk factors for positive PC

    Time frame: 4 years

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Study locations

1 site
  • Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
    Tel Aviv, Israel
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2019 (actual). Primary completion is estimated for Dec 2024, 62 months after the start.

Of 223 non-industry observational studies under Crohn Disease, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 90. This study's planned 62 months is above that.

Counting every sponsor, half of 296 studies reached it within 42 months; a quarter within 29 and three quarters within 81.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2024
First posted
Jul 23, 2024
StartActual
Sep 11, 2019
Primary completionEst.
Dec 1, 2024
CompletionEst.
Jul 1, 2025
Last update
Jul 25, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06515171
Lead sponsor
Shmuel Kivity, MD
Responsible party
Shmuel Kivity, MD (Professor, Tel-Aviv Sourasky Medical Center) — Sponsor-investigator
First posted
Jul 23, 2024
Start date
Sep 11, 2019
Primary completion
Dec 1, 2024 (estimated)
Completion
Jul 1, 2025 (estimated)
Last update
Jul 25, 2024

Study contacts

Nitsan Maharshak, MD
principal investigator · Sourasky Medical Center and Tel-Aviv University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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