Trial Outcomes & Findings for Evaluation of Blood as a Submucosal Cushion During Endoscopic Polypectomy and Mucosal Resection (NCT NCT00583466)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Immediately after the procedure, Up to 5 minutes

Results posted on

2017-09-13

Participant Flow

No data on how participants were randomized, and no further baseline data (other than categorical age and sex) are available for this record. The PI has left the institution and has been contacted. Per the PI the data are no longer available and the study has not been published.

Participant milestones

Participant milestones
Measure	All Participants Polypectomy with normal saline injected for submucosal cushion creation Normal saline: Normal saline will be injected under the lesion to create submucosal cushion OR Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion HPMC: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion OR Polypectomy after injection of autologous blood Autologous blood injection: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Blood as a Submucosal Cushion During Endoscopic Polypectomy and Mucosal Resection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=18 Participants Polypectomy with normal saline injected for submucosal cushion creation Normal saline: Normal saline will be injected under the lesion to create submucosal cushion OR Polypectomy after injection of hydroxypropyl methylcellulose (HPMC) to create submucosal cushion HPMC: Hydroxypropyl methylcellulose (HPMC) will be injected under the lesion to create submucosal cushion OR Polypectomy after injection of autologous blood Autologous blood injection: Autologous blood will be drawn from the patient and then reinjected under the lesion to create a safety cushion
Age, Customized >= 18, <= 90	18 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately after the procedure, Up to 5 minutes

Population: No data is available for this record. The PI has left the institution and has been contacted. Per the PI the data is no longer available and the study has not been published.

Outcome measures

Outcome data not reported

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Johns Hopkins ClinicalTrials.gov Program

Johns Hopkins University

Phone: 410-550-6484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place