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SmartPill Motility System & PillCam Patency Capsule for Cystic Fibrosis

Q: Has the FDA given authorization to use SmartPill Motility System & PillCam Patency Capsule?

<p>The SmartPill Motility System &#x26; PillCam Patency Capsule is rated a 3 on our safety scale, as the trial has been approved and entered Phase 4.</p>

Q: To what ailments does the SmartPill Motility System & PillCam Patency Capsule offer relief?

<p>SmartPill Motility System &#x26; PillCam Patency Capsule are frequently used to ameliorate dyschezia. Additionally, this technology has been effective at managing the symptoms of exophthalmos, constipation, and colonoscopy.</p>

Phase 4

Waitlist Available

Led By Dhiren Patel, MD

Research Sponsored by St. Louis University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change is being assessed: total intestinal transit time (measured in hours) at baseline and two weeks following initiation of therapy

Awards & highlights

Study Summary

This trial is testing a new way to measure constipation in patients with cystic fibrosis, and whether a common constipation medication is effective.

Eligible Conditions

Cystic Fibrosis Gastrointestinal Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change is being assessed: total intestinal transit time (measured in hours) at baseline and two weeks following initiation of therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change is being assessed: total intestinal transit time (measured in hours) at baseline and two weeks following initiation of therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and change is being assessed: total intestinal transit time (measured in hours) at baseline and two weeks following initiation of therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change is being assessed: total intestinal transit time at baseline and two weeks following initiation of therapy

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention with polyethylene glycol & SmartPillExperimental Treatment2 Interventions

Patients will ingest a Smart pill to obtain baseline motility within the GI lumen. All patients will undergo intervention with taking polyethylene glycol (PEG) or Miralax (brand name) 17 grams once daily. After two weeks of therapy, the patient will repeat the motility survey and again ingest a smart pill to assess the change in motility symptoms while on therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Polyethylene Glycol 3350

2023

Completed Phase 4

~510

SmartPill Motility System & PillCam Patency Capsule

2019

Completed Phase 4

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

St. Louis UniversityLead Sponsor

194 Previous Clinical Trials

43,652 Total Patients Enrolled

1 Trials studying Cystic Fibrosis

1 Patients Enrolled for Cystic Fibrosis

Dhiren Patel, MDPrincipal Investigator - St. Louis University

SSM Cardinal Glennon Children's Hospital, Saint Louis University @ Cardinal Glennon Childrens Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of participant would be most advantageous for this clinical investigation?

"This fibrosis research study is looking to enrol 15 patients, aged 18-40, who suffer from cystic fibrosis. To qualify for the trial they must have a confirmed diagnosis of CF via genetic mutations as well as demonstrate symptoms such as infrequent bowel movements or difficulty evacuating their bowels. Participants are allowed to be on CFTR modulators and/or receiving enteral feeding during the course of the trial."

Answered by AI

Could you please provide an overview of the prior research done with SmartPill Motility System & PillCam Patency Capsule?

"Currently, 16 medical experiments are underway related to the SmartPill Motility System & PillCam Patency Capsule. Not a single one is in Phase 3 at this time; however, these trials span 25 locations with most of them being based in Tempe, Arizona."

Answered by AI

Has the FDA given authorization to use SmartPill Motility System & PillCam Patency Capsule?

"The SmartPill Motility System & PillCam Patency Capsule is rated a 3 on our safety scale, as the trial has been approved and entered Phase 4."

Answered by AI

Does this research initiative accept participants aged 30 or older?

"This clinical trial requires participants to be between 18 and 40 years old. There are 110 trials available for minors, while those over 65 can participate in 432 studies."

Answered by AI

Is enrollment still available to participants for this trial?

"The trial, posted on December 12th 2019 and last revised June 8th 2022, is in need of participants as per information available on clinicaltrials.gov."

Answered by AI

To what ailments does the SmartPill Motility System & PillCam Patency Capsule offer relief?

"SmartPill Motility System & PillCam Patency Capsule are frequently used to ameliorate dyschezia. Additionally, this technology has been effective at managing the symptoms of exophthalmos, constipation, and colonoscopy."

Answered by AI

What is the recruitment quota for this clinical evaluation?

"Affirmative. According to clinicaltrials.gov, this experiment is in the process of seeking participants and was first shared on December 12th 2019 with a last update made June 8th 2022. 15 candidates are being sought between two distinct sites."

Answered by AI

Recent research and studies

ANZ Journal of SurgeryJournal

Staged Bentall Procedure and Extra-anatomical Repair of Coarctation of Aorta

Xu, Robert B., Ritwick R. Bhuyan, and James R. M. Edwards. 2014. “Staged Bentall Procedure and Extra-anatomical Repair of Coarctation of Aorta”. ANZ Journal of Surgery. Wiley. doi:10.1111/ans.12666.

GastroenterologyJournal

Development and Validation of the Rome IV Diagnostic Questionnaire for Adults

Palsson, Olafur S., William E. Whitehead, Miranda A.L. van Tilburg, Lin Chang, William Chey, Michael D. Crowell, Laurie Keefer, et al.. 2016. “Development and Validation of the Rome IV Diagnostic Questionnaire for Adults”. Gastroenterology. Elsevier BV. doi:10.1053/j.gastro.2016.02.014.

Journal of Cystic FibrosisJournal

Impaired Gastric Myolectrical Activity in Patients with Cystic Fibrosis

Bentur, Lea, Bayan Hino, Raanan Shamir, Nael Elias, Corina Hartman, Orly Eshach-Adiv, and Drora Berkowitz. 2006. “Impaired Gastric Myolectrical Activity in Patients with Cystic Fibrosis”. Journal of Cystic Fibrosis. Elsevier BV. doi:10.1016/j.jcf.2006.03.003.

Journal of Cystic FibrosisJournal