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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03508076
Other study ID # Vibrating Capsule
Secondary ID
Status Recruiting
Phase N/A
First received April 23, 2017
Last updated April 16, 2018
Start date February 1, 2017
Est. completion date June 30, 2018

Study information

Verified date April 2018
Source Changhai Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Constipated patients in the participating center from February 2017 to June 2018 (anticipated) were prospectively enrolled. Number of defecation per week,Bristol score,and Colon transmission experiment were compared with the constipated patients before treatment.


Description:

Constipation affects the quality of life of patients, some patients abuse laxatives or repeated medical treatment, increased medical costs. At present, the main treatment of constipation is to adjust life style, medicine, psychotherapy, biofeedback and surgical treatment. However, the above methods are associated with adverse reactions, and the patient's satisfaction is still low. A new approach is needed to solve this clinical problem.

Investigators have developed a vibration capsule that can be adjusted in different modes.

Preliminary animal experiments showed that the capsule was safe and increased the number of defecation.

This study is a clinical research for patients with constipation, to explore the effect in different vibrating modes in patients with constipation and tract emptying transmission and its effectiveness.


Recruitment information / eligibility

Status Recruiting
Enrollment 27
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Adult patients aged form 18 to 80

- Clinical diagnosis of functional constipation

- Must be able to swallow vibrating capsule

Exclusion Criteria:

- complex history of gastrointestinal diverticula, obstruction, ulcer, bleeding, stenosis or fistula.

- recent use of banned drugs.

- patients who are preparing for mri.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Vibrating Capsule
Patients in this group would be treated with Vibrating Capsule
Sham Capsule
Capsules can't vibrate but look the same as Vibrating Capsule

Locations

Country Name City State
China Changhai Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Yu J, Qian YY, He CH, Zhu SG, Zhao AJ, Zhu QQ, Shao CW, Wang TG, Wang Y, Ding GL, Liao Z, Li ZS. Safety and Efficacy of a New Smartphone-controlled Vibrating Capsule on Defecation in Beagles. Sci Rep. 2017 Jun 6;7(1):2841. doi: 10.1038/s41598-017-02844-4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary defecation frequency the average weekly defecation frequency 8 weeks
Secondary Bristol Stool Chart Record the BSC of each defecation. 8 weeks
Secondary first defecation The time of complete defecation after taking the capsule for the first time 8 weeks
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