Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Patients with Ulcerative Proctitis, a Pilot Study

Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Patients with Ulcerative Proctitis, a Pilot Study - Photopill treatment for Ulcerative Proctitis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40086

Enrollment

Registered

2012-12-04

Start date

2013-01-07

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease Ulcerative Colitis

Interventions

After the rectum of the patient is cleaned with a Saline enema, the Photopill suppository capsule, mounted on a flexible rectal tube, will be inserted to the rectum to the pre-determined distance(ba

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Diagnosed with Ulcerative Proctitis (Naïve or failing on stable dose of 5-ASA agents 8 weeks prior to day 0). * Visible evidence for Ulcerative Proctitis in the rectum at the relevant treated area. * Mild to moderate Ulcerative Proctitis Mayo grade 1 or 2 * Able and willing to travel 3 times a week to the clinic. * Subject willing to sign an Informed Consent * 18

Exclusion criteria

Exclusion criteria: * Symptomatic hemorrhoids * Pregnant or lactating females * Patients that have used any experimental treatment within 8 weeks prior to Day 0 * Patients that have used any biologics therapies and/or steroids 4 weeks prior to Day 0 * Rectal therapy 2 weeks prior to Day 0 * Dose change in immunosuppression (azathioprine, 6-MP) in the previous 3 months

Design outcomes

Primary

Measure	Time frame
* Safety evaluation of the device as determined by the number and severity of Adverse Events in comparison to the baseline condition [Time Frame: Day 0 day 14, Day 28, Day 42 and unscheduled visits] * Comparison between baseline sigmoidoscopy assessments of mucosal appearance of the diseased area, and the follow up assessments of the diseased area, according to the Mayo score [ Time Frame: Day 0, Day 14, Day 28 and Day 42] * Comparison of Clinical Questionnaires partial Mayo score and SSCAI at baseline and at day 42.	—

Measure

Time frame

* Safety evaluation of the device as determined by the number and severity of Adverse Events in comparison to the baseline condition [Time Frame: Day 0 day 14, Day 28, Day 42 and unscheduled visits] * Comparison between baseline sigmoidoscopy assessments of mucosal appearance of the diseased area, and the follow up assessments of the diseased area, according to the Mayo score [ Time Frame: Day 0, Day 14, Day 28 and Day 42] * Comparison of Clinical Questionnaires partial Mayo score and SSCAI at baseline and at day 42.

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Secondary

Measure	Time frame
* Concentration of Inflammatory cells and mediators (cytokines, macrophages, and lymphocytes) in the tissue, as detected by histological assessment of biopsies taken from the diseased area . A comparison will be made between the baseline measurements and follow up measurements of the diseased area [ Time Frame: Day 0, Day 14, Day 28 and Day 42] * Comparison of inflammatory markers in serum (CRP) and stool (calprotectin) as collected at day 0 (baseline), 14, 28 and 42.	—

Measure

Time frame

* Concentration of Inflammatory cells and mediators (cytokines, macrophages, and lymphocytes) in the tissue, as detected by histological assessment of biopsies taken from the diseased area . A comparison will be made between the baseline measurements and follow up measurements of the diseased area [ Time Frame: Day 0, Day 14, Day 28 and Day 42] * Comparison of inflammatory markers in serum (CRP) and stool (calprotectin) as collected at day 0 (baseline), 14, 28 and 42.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)